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Dissolution Methods

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0% found this document useful (0 votes)
253 views

Dissolution Methods

Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as XLSX, PDF, TXT or read online on Scribd
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Drug Name Dosage Form USP Apparatus

Bismuth Subsalicylate BiSub: Tablet


(BiSub)/Metronidazole (Chewable) /Met:Tablet II (Paddle)
(Met)/Tetracycline HCl (Tet) /Tet: Capsule
Buccal Tablet (Extended
Testosterone II (Paddle, may use sinker)
Release)
Acalabrutinib Capsule
Acetaminophen/Caffeine/ Capsule I (Basket)
Dihydrocodeine Bitartrate
Acitretin Capsule
Acrivastine/Pseudoephedrine
Capsule II (Paddle)
HCl
Acyclovir Capsule
Altretamine Capsule
Alvimopan Capsule II (Paddle
Amantadine HCl Capsule
Amlodipine
Capsule I (Basket)
Besylate/Benazepril HCl
Amoxicillin Capsule

Amphetamine ER Capsule II (Paddle)


Ampicillin/Ampicillin
Capsule I (Basket)
Trihydrate
Amprenavir Capsule II (Paddle)
Anagrelide HCl Capsule I (Basket)
Aprepitant Capsule II (Paddle)
Aspirin Capsule
Aspirin/Butalbital/Caffeine Capsule
Aspirin/Butalbital/Caffeine/
Codeine Phosphate Capsule
Aspirin/Dipyridamole Capsule I (Basket)
Atazanavir Sulfate Capsule II (Paddle)
Atomoxetine HCl Capsule
Auranofin Capsule II (Paddle)
Azithromycin Capsule
Balsalazide Disodium Capsule II (Paddle) with sinker
Benzonatate Capsule
Berotralstat HCl Capsule
Betrixaban Capsule

Bexarotene Capsule II (Paddle)


Bismuth Subcitrate
Potassium/Metronidazole/Tet Capsule II (Paddle)
racycline
BoceprevirHCl Capsule II (Paddle) with sinker
Budesonide Capsule II (Paddle) with sinker
Calcitriol Capsule
Calcium Acetate Capsule
Cariprazine HCl Capsule I (Basket)
Cefaclor Capsule
Cefadroxil Capsule
Cefdinir Capsule II (Paddle)
Cefixime Capsule I (Basket)

Celecoxib Capsule II (Paddle)

Cephalexin Capsule
Ceritinib Capsule II (Paddle)
Cevimeline HCL Capsule
Chlordiazepoxide HCl/
Capsule
Clidinium Bromide
Citalopram Hydrobromide Capsule II (Paddle)
Clindamycin HCl Capsule
Clomipramine HCl Capsule
Cycloserine Capsule
Cysteamine Bitartrate Capsule I (Basket)
I (Basket) for 75 strength:
I (Basket with
Dabigatran Etexilate Mesylate Capsule modified diameter of 24.5
mm) for 150 mg strength:
Dabrafenib Mesylate Capsule II (Paddle)
Danazol Capsule
Dantrolene Sodium Capsule I (Basket)
Demeclocycline
Dextromethorphan HCl Capsule
Hydrobromide/Quinidine Capsule I (Basket)
Sulfate
Diclofenac Capsule I (Basket)
Diclofenac Potassium Capsule II (Paddle
Dicloxacillin Sodium Capsule
Diphenhydramine
Capsule I (Basket)
HCl/Ibuprofen
Disopyramide Phosphate Capsule
Dofetilide Capsule
Doxepin HCl Capsule
Doxercalciferol Capsule
Doxycycline Hyclate Capsule
Dronabinol Capsule II (Paddle)
Droxidopa Capsule
Dutasteride: II (Paddle) with
Dutasteride/Tamsulosin HCl Capsule sinker. Tamsulosin: II
(Paddle)

II (Paddle) A sinker may be


Efavirenz Capsule used with justification if
necessary.
Eliglustat Tartrate Capsule
Emtricitabine Capsule
Entrectinib Capsule II (Paddle) with Sinker

Enzalutamide Capsule II (Paddle) with sinker

Ergocalciferol Capsule II (Paddle)


Escitalopram Oxalate Capsule

III (Reciprocating Cylinder)


Estradiol/Progesterone Capsule [40 mesh for bottom and top
of the inner tube]
Estramustine Phosphate
Ethinyl Capsule I (Basket)
Sodium
Estradiol/Norethindrone Capsule II (Paddle)
Acetate
Ethosuximide Capsule
Etoposide Capsule
Fedratinib HCl Capsule I (Basket)
Fenofibrate Capsule II (Paddle)
Fenoprofen Calcium Capsule
Ferric Maltol Capsule II (Paddle with sinker)
Fexofenadine HCl Capsule II (Paddle)
Fingolimod Capsule I (Basket)
Flucytosine Capsule
Fluoxetine HCl Capsule
Fluoxetine/Olanzapine Capsule II (Paddle)
Flutamide Capsule
Fluvastatin Sodium Capsule
Gabapentin Capsule
Ganciclovir Capsule II (Paddle)
Hydrochlorothiazide Capsule
Hydrochlorothizide/ Capsule
Triamterene
Hydroxyurea Capsule
Hydroxyzine Pamoate Capsule
Ibrutinib Capsule II (Paddle)
Ibuprofen Sodium Capsule I (Basket)
Ibuprofen/Diphenhydramine Capsule I (Basket)
Ibuprofen/Pseudoephedrine Capsule I (Basket)
HCl

Icosapent Ethyl Capsule

Imipramine Pamoate Capsule I (Basket)

Indinavir Sulfate Capsule II (Paddle)


Indomethacin (40 mg and 20
Capsule I (Basket)
mg)
Indomethacin (50 and 25 mg) Capsule
Isotretinoin Capsule
Isradipine Capsule II (Paddle)
Itraconazole Capsule II (Paddle)
Ketoprofen Capsule II (Paddle with sinker)
Lenalidomide Capsule II (Paddle)
Linaclotide Capsule I (Basket)
Lisdexamfetamine Dimesylate Capsule
Lithium Carbonate Capsule
Lomitapide Mesylate Capsule II (Paddle)
Lomustine Capsule
Lonafarnib Capsule I (Basket)
Loperamide HCl Capsule
Mefenamic Acid Capsule
Meloxicam Capsule I (Basket)
Methoxsalen Capsule
Methyltestosterone Capsule
Metronidazole Capsule
Metyrosine Capsule
Mexiletine HCl Capsule
Midostaurin Capsule II (Paddle)
Miglustat Capsule I (Basket)
Minocycline HCl Capsule
Minocycline HCl Capsule
Mycophenolate Mofetil Capsule II (Paddle)
Nabilone Capsule II (Paddle)
Naproxen Sodium Capsule II (Paddle)

Netupitant/Palonosetron HCl Capsule II (Paddle)

Nicardipine HCl Capsule II (Paddle)


Nifedipine Capsule
Nilotinib Hydrochloride Capsule I (Basket)
Monohydrate
Nimodipine Capsule II (Paddle)
Nintedanib Esylate Capsule II (Paddle) with sinker

Niraparib Capsule II (Paddle) with sinker

Nitisinone Capsule II (Paddle) with sinker


Nitrofurantoin Capsule
Nizatidine Capsule
Nortriptyline HCl Capsule
Olsalazine Sodium Capsule I (Basket)
Omeprazole Sodium
Capsule II (Paddle)
Bicarbonate
Opicapone Capsule I (Basket with sinker)

Orlistat Capsule II (Paddle)


Oseltamivir Phosphate Capsule
Oxycodone HCl Capsule
Ozanimod HCl Capsule
Palonosetron HCl Capsule
Paricalcitol Capsule I (Basket)
Paromomycin Sulfate Capsule
Paroxetine Mesylate Capsule
Penicillamine Capsule
Pentosan Polysulfate Sodium Capsule I (Basket)
Phendimetrazine Tartrate Capsule
Phenoxybenzamine HCl Capsule
Phentermine HCl Capsule
Phenytoin Sodium Capsule
Pirfenidone Capsule
Piroxicam Capsule
Pomalidomide Capsule II (Paddle)
Pralsetinib Capsule II (Paddle) with sinker
Prazosin HCl Capsule
Pregabalin Capsule
Progesterone Capsule
Quinine Sulfate Capsule
Ramipril Capsule
Ranitidine HCl Capsule II (Paddle)
Ribavirin Capsule I (Basket)
Rifabutin Capsule
Rifampin Capsule
Ritonavir Capsule
Rivastigmine Tartrate Capsule
Saquinavir Mesylate Capsule
Selegiline HCl Capsule
Selpercatinib Capsule II (Paddle)
Selumetinib Capsule II (Paddle) with sinker
Sevelamer HCl Capsule
Sibutramine HCl Capsule II (Paddle)
Silodosin Capsule
Simeprevir Sodium Capsule II (Paddle)
Sodium Iodide I-123 Capsule I (Basket)
Sodium Iodide I-131 Capsule
Stavudine Capsule
Succimer Capsule II (Paddle)
Sunitinib Malate Capsule
Tacrolimus Capsule II (Paddle)

Tafamidis Capsule II (Paddle) with sinker

Tafamidis Meglumine Capsule II (Paddle) with sinker

Talazoparib Tosylate Capsule II (Paddle) with sinker


Tamsulosin HCl Capsule II (Paddle)
Tasimelteon Capsule
Temazepam Capsule
Temozolomide Capsule
Terazosin HCl Capsule II (Paddle)
Testosterone Undecanoate Capsule II (Paddle)
Tetracycline HCl Capsule
Thalidomide Capsule II (Paddle)
Tipranavir Capsule II (Paddle)

Tivozanib HCl Capsule II (Paddle with sinker)

Tizanidine HCl Capsule


Topotecan HCl Capsule II (Paddle)
Tretinoin Capsule I (Basket)
Trientine HCl Capsule
Trimipramine Maleate Capsule
Valbenazine Capsule II (Paddle) with sinker
Valproic Acid Capsule
Valsartan Capsule II (Paddle)
Vancomycin hydrochloride Capsule
Vismodegib Capsule II (Paddle)
Voclosporin Capsule II (Paddle)
Vorinostat Capsule II (Paddle) with sinker
Zaleplon Capsule
Zinc Acetate Capsule II (Paddle)

Ziprasidone HCl Capsule II (Paddle)

Didanosine Capsule (Delayed Release I (Basket)


Pellets) Release
Capsule (Delayed
Esomeprazole Magnesium
Pellets)
Amoxicillin/Omeprazole Capsule (Delayed Release) I (Basket
Mg./Rifabutin
Choline Fenofibrate Capsule (Delayed Release) II (Paddle)
Cysteamine Bitartrate Capsule (Delayed Release) I (Basket)
Dexlansoprazole Capsule (Delayed Release) I (Basket)
Diroximel Fumarate Capsule (Delayed Release) II (Paddle) with sinker

Doxycycline Capsule (Delayed Release) II (Paddle)

Lansoprazole Capsule (Delayed Release)

Mesalamine Capsule (Delayed Release) II (Paddle)

II (Paddle) Stationary Basket


Monomethyl Fumarate Capsule (Delayed Release)
over the Paddle
Octreotide Acetate Capsule (Delayed Release) II (Paddle with sinker)
Omeprazole Capsule (Delayed Release)

Rabeprazole Sodium Capsule (Delayed Release) II (Paddle)

Divalproex Sodium Capsule (Delayed Release)


Duloxetine HCl Capsule (Delayed Release)
Pancrelipase Capsule (Delayed Release)
Acetazolamide Capsule (Extended II (Paddle)
Release)
Amphetamine
Aspartate/Amphetamine
Capsule (Extended
Sulfate/Dextroamphetamine II (Paddle)
Release)
Saccharate/Dextroamphetami
Amphetamine
ne Sulfate
Aspartate/Amphetamine
Sulfate/Dextroamphetamine Capsule (Extended
II (Paddle)
Saccharate/Dextroamphetami Release)
ne Sulfate [12.5, 25, 37.5, 50
mg] Capsule (Extended
Carvedilol Phosphate
Chlorpheniramine II (Paddle)
Release)
Capsule (Extended
Polistirex/Hydrocodone II (Paddle)
Release)
Capsule (Extended
Polistirex
Dexmethylphenidate HCl I (Basket)
Release)
Capsule (Extended
Dextroamphetamine Sulfate I ( Basket)
Release)
Capsule (Extended
Diltiazem HCl (AB2)
Release)
Capsule (Extended
Diltiazem HCl (AB3)
Release)
Capsule (Extended
Diltiazem HCl (AB4)
Release)
Capsule (Extended
Disopyramide Phosphate
Donepezil HCl/Memantine Release)
Capsule (Extended
I (Basket)
HCl Release)
Capsule (Extended
Fluvoxamine Maleate II (Paddle)
Release)
Capsule (Extended
Galantamine HBr II (Paddle)
Release)
Hydrocodone Bitartrate Capsule (Extended I (Basket)
Release)
Capsule (Extended
Indomethacin
Release)
Capsule (Extended
Isosorbide Dinitrate
Release)
Capsule (Extended
Levomilnacipran HCl II (Paddle)
Release)
Capsule (Extended
Lorazepam I (Basket)
Mesalamine (250 mg and 500 Release)
Capsule (Extended
mg) Release)
Capsule (Extended
Mesalamine (375 mg) I (Basket)
Release)
Capsule (Extended
Methylphenidate II (Paddle)
Release)
Capsule (Extended
Methylphenidate (BX) I (Basket)
Release)
Capsule (Extended
Morphine Sulfate
Release)
Capsule (Extended
Nicardipine HCl II (Paddle)
Release)
Capsule (Extended
Phendimetrazine Tartrate II (Paddle)
Release)
Capsule (Extended
Propafenone HCl
Release)
Capsule (Extended
Propranolol HCl
Release)
Capsule (Extended
Theophylline Release)
Capsule (Extended
Tolterodine Tartrate I (Basket)
Topiramate [25, 50, 100, 150 Release)
Capsule (Extended
I (Basket)
mg and
Topiramate 200
[25, mg]
50, 100 and Release)
Capsule (Extended
II (Paddle)
200 mg] Release)
Capsule (Extended
Tramadol I (Basket)
Release)
Capsule (Extended
Trospium Chloride II (Paddle) with sinker
Release)
Capsule (Extended
Venlafaxine HCl I (Basket)
Release)
Capsule (Extended
Verapamil HCl
Release)
Capsule (Extended
Viloxazine HCl II (Paddle) with sinker
Release)
Capsule (Extended
Aspirin II (Paddle) with sinker
Release)
Capsule (Extended
Calcifediol II (Paddle) with sinker
Release)
Capsule (Extended
Carbamazepine II (Paddle)
Release)
Capsule (Extended
Carvedilol Phosphate II (Paddle)
Release)
Capsule (Extended
Cyclobenzaprine
Release)
Capsule (Extended
Memantine HCl I (Basket)
Release)
Capsule (Extended
Methylphenidate HCl I (Basket)
Release)
Methylphenidate HCl (25 mg,
Capsule (Extended
35 mg, 45 mg, 55 mg, 70 mg II (Paddle) with sinker
Release)
and 85 mg)
Capsule (Extended
Minocycline HCl I (Basket- 10 mesh)
Release)
Capsule (Extended
Morphine Sulfate (AB2) II (Paddle)
Release)
Morphine Sulfate/Naltrexone Capsule (Extended II (Paddle)
HCl Release)
Naltrexone HCl / Oxycodone Capsule (Extended
HCl Release)
Capsule (Extended
Oxycodone I (Basket)
Release)
Capsule (Extended
Phentermine HCl/Topiramate I (Basket)
Release)
Capsule (Extended
Potassium Chloride
Release)
Cyclosporine (100 mg) (AB1) Capsule (Liquid filled) II (Paddle)
Fenofibrate Capsule (Micronized) II (Paddle)
Aliskiren Hemifumarate Capsule (pellet) I (Basket)
Cetirizine Capsule (Soft-Gelatin) II (Paddle)

Dutasteride Capsule (Soft-Gelatin) II (Paddle)

Lopinavir/Ritonavir Capsule (Soft-Gelatin) II (Paddle)

Lubiprostone Capsule (Soft-Gelatin) II (Paddle)


Loratadine Capsule (Soft-Gelatin) II (Paddle) with sinker
Capsule
Ibuprofen Potassium I (Basket)
(Soft-Gelatin/Liquid
Capsule Fill)
Ibuprofen I (Basket)
(Soft-Gelatin/Liquid Fill)
Topiramate Capsule (Sprinkle) II (Paddle)
Acetaminophen/Butalbital/ Capsule II (Paddle)
Caffeine/Codeine Phosphate
Alectinib HCl Capsule II (Paddle) with sinker
Cabozantinib S-Malate Capsule II (Paddle) with sinker
Cholic Acid Capsule II (Paddle) with sinker
Crizotinib Capsule I (Basket)
Cyclosporine Capsule

Isavuconazonium Sulfate Capsule II (Paddle) with sinker

Lenvatinib Mesylate Capsule II (Paddle)


Miltefosine Capsule
Olaparib Capsule II (Paddle)

Omega-3-Acid Ethyl Esters Capsule

Palbociclib Capsule II (Paddle) with sinker

Sonidegib Phosphate Capsule II (Paddle) with sinker

Zonisamide Capsule II (Paddle)


Colchicine Capsule II (Paddle)
Ixazomib Citrate Capsule I (Basket)
Panobinostat Lactate Capsule
Capsule  (Delayed
Dimethyl Fumarate II (Paddle)
Release)
Capsule (Extended
Carbidopa/Levodopa I (Basket)
Release)

Amoxicillin/Clarithromycin/ Capsule/Tablet/Capsule
Lansoprazole (Copackage)
Amoxicillin/Clarithromycin/ Capsule/Tablet/Capsule
Omeprazole (Copackage)
Procarbazine HCl Capsules II (Paddle)
Ursodiol Capsules
Capsules (Delayed
Fluoxetine
Release)
Reciprocating Cylinder
Lanthanum Carbonate Chewable Tablet (Apparatus 3 modified)
Chewing Machine as
Nicotine Polacrilex Chewing Gum desribed in European
Pharmacopoeia (2.9.25)
Delayed Release Granules
Pantoprazole Sodium for Oral Suspension II (Paddle)

Minocycline HCl
Chlorpheniramine ER Tablets I (Basket)
Extended Release Oral II (Paddle)
Polistirex/Hydrocodone Suspension
Polistirex
V (Paddle over Disk), with 56
Clobazam Film mm, 40 mesh stainless steel
disk.
I (Basket)  100 mL round
Buprenorphine HCl Film (Buccal)
bottom vessel
Fentanyl Citrate (0.2 mg, 0.4 I (Basket) 100 mL dissolution
Film (Buccal)
mg, 0.6 mg and 0.8 mg) vessel
I (Basket) 100 mL dissolution
Fentanyl Citrate (1.2 mg) Film (Buccal)
vessel
V (Paddle over Disk) with a
Ondansetron Film (Oral) stainless steel disk (120 mesh
screens)
Apomorphine HCl Film (Sublingual) V (paddle over disk)
V (Paddle over Disk) with 56
Buprenorphine HCl/Naloxone
Film (Sublingual) mm, 40 mesh stainless steel
HCl
disk.
Ethinyl Estradiol; Modified USP Type V
Film, Transdermal
Norelgestromin (Paddle-over-disk)
Modified USP Type VI
Rivastigmine Film, Transdermal
(cylinder)
Film, Transdermal VI (Cylinder) with adapter, if
Buprenorphine
(Extended Release) needed
Film, Transdermal
Estradiol (0.014 mg/24 hr)
Estradiol (0.025 mg/24 hr, (Extended Release)
0.0375 mg/24 hr, 0.05 mg/24 Film, Transdermal
hr, 0.06 mg/24 hr, 0.075 (Extended Release)
mg/24 hr and
Estradiol 0.11)mg/24
(Test (0.025hr) VI (Cylinder) attach the patch
mg/24 hr, 0.0375 mg/24 hr, Film, Transdermal
to a disk at the bottom of the
0.05 mg/24 hr, 0.075 mg/24 (Extended Release)
cylinder
hr and 0.1 mg/24 hr)
Estradiol (Test 2) (0.05 mg/24 Film, Transdermal V (Paddle over Disk) with a
hr and 0.1 mg/24 hr) (Extended Release) stainless steel disk

Estradiol (Test 3) 0.0375


VI (Cylinder) attach the patch
mg/24 hr, 0.05 mg/24 hr, Film, Transdermal
to the cylinder with double-
0.075 mg/24 hr and 0.1 (Extended Release)
sided tape
mg/24 hr)

Film, Transdermal V (Paddle over disk). Paddle


Testosterone 25 mm above the film on the
(Extended Release)
disk.
Film, Transdermal
Granisetron VI (Cylinder)
(Extended Release)
Film, Transdermal
Nicotine (Extended Release)
Film,
Transdermal (Extended Modified USP Type V
Nitroglycerin
Release) (Paddle-over-disk)
For Intramuscular
Aripiprazole Suspension (Extended II (Paddle)
Release)
For Intramuscular
IV (Flow through cell), 22.6
Olanzapine Pamoate Suspension (Extended
mm cell
Release)
For Intramuscular
Triptorelin Pamoate Suspension (Extended II (Paddle)
Release)
Ampicillin/Ampicillin
for Oral Suspension II (Paddle)
Trihydrate
Cefprozil For Oral Suspension II (Paddle)
Fidaxomicin For Oral Suspension II (Paddle)
Esomeprazole Magnesium For Oral Suspension II (Paddle
(Delayed Release)
Amoxicillin For Oral Suspension II (Paddle)
Aprepitant For Oral Suspension II (Paddle)
Baloxavir Marboxil For Suspension II (Paddle)
Fosfomycin Tromethamine For Suspension
Tacrolimus For Suspension II (Paddle)
For suspension (Delayed
Omeprazole Magnesium II (Paddle)
Release)
For Suspension (Delayed
Posaconazole II (Paddle)
Release)
For Suspension (Extended
Metformin HCl II (Paddle)
Release)
For suspension
Dantrolene Sodium (Intravenous ) II (Paddle)
For Suspension, Extended
Exenatide Synthetic (2 mg)
Release
Diazepam Gel (Rectal) II (Paddle)
Dapsone Gel (Topical)
Deferasirox Granule II (Paddle)
Montelukast Granule I (Basket) (100 mesh)
Secnidazole Granule I (Basket)
Uridine Triacetate Granule II (Paddle)
Aminosalicylic Granule (Delayed Release) II (Paddle)

Cysteamine Bitartrate Granule (Delayed Release) I (Basket

Granules (Extended
Ranolazine
Erythromycin II (Paddle)
Release)
Granules for Oral
Ethylsuccinate/Sulfisoxazole
Suspension
Acetyl Granules, for Oral
Mirabegron Suspension (Extended II (Paddle)
Release)
Buprenorphine HCl Implant II (Paddle

Prior to sampling, the jar is


removed from incubation
Goserelin Acetate Implant
and mechanically swirled
with digital orbital shaker

Leuprolide Acetate Implant


VII (with reciprocating 50
Dexamethasone Implant (Intravitreal)
mesh baskets)
Penicillin G Benzathine Injectable

Risperidone Injectable

Verteporfin Injectable
Granisetron Injectable (Extended
Release)
Leuprolide Acetate Injectable (Extended
Release)

Octreotide Injection Injectable (Extended


Release)

Doxorubicin HCl Injectable (Liposomal)

Amphotericin B Injectable (Liposomal)


Azacitidine Injectable Suspension
Betamethasone
Acetate/Betamethasone Injectable Suspension IV (Flow through cell)
Sodium Phosphate
Triptorelin Pamoate Injectable Suspension II (Paddle)
Injectable Suspension IV (Flow through cell-closed
Ciprofloxacin
[Otic] loop) / 22 mm

Test 1: IV (Flow through cell),


Medroxyprogesterone
Injectable Suspension 22.6 mm cell, 13 g of 1 mm
Acetate
beads; Test 2: II (Paddle)
Medroxyprogesterone
Injectable Suspension
Acetate (104mg/0.65ml)
IV (Flow-Through Cell-Open
Methylprednisolone Acetate Injectable Suspension
system)
Naltrexone Injectable Suspension

Triamcinolone Acetonide Injectable Suspension


Intra-Articular, For
Triamcinolone Acetonide Suspension (Extended II (Paddle)
Release)
Intramuscular Suspension
Paliperidone Palmitate II (Paddle)
Paliperidone Palmitate [3- (Extended Release)
Intramuscular Suspension
II (Paddle)
month injection] (Extended Release)
Levonorgestrel Intrauterine Device
Clotrimazole Lozenge
Nicotine Polacrilex Lozenge I (Basket)

Nicotine Polacrilex Lozenge (Mini) III (Reciprocating Cylinder)

Fentanyl Citrate Lozenges II (Paddle)


Brimonidine
Tartrate/Brinzolamide Ophthalmic Suspension
Dexamethasone/Neomycin
Ophthalmic Suspension
Sulfate/ Polymyxin B Sulfate
Dexamethasone/Tobramycin Ophthalmic Suspension
Loteprednol Etabonate Ophthalmic Suspension
Nepafenac Ophthalmic Suspension
Rimexolone Ophthalmic Suspension
Brinzolamide Ophthalmic Suspension
Loteprednol Ophthalmic Suspension
Etabonate/Tobramycin
Prednisolone Acetate Ophthalmic Suspension
Erythromycin Ethylsuccinate Oral granule
Atovaquone Oral Suspension
Azithromycin Oral Suspension II (Paddle)
Ciprofloxacin Oral Suspension II (Paddle)
Clobazam Oral Suspension II (Paddle)
Darunavir Ethanolate Oral Suspension II (Paddle)
Diazoxide Oral suspension
Fosamprenavir Calcium Oral Suspension II (Paddle)
Griseofulvin Oral Suspension II (Paddle)
Griseofulvin (Microcrystalline) Oral Suspension II (Paddle)
Loperamide HCl Oral Suspension II (Paddle)
Megestrol Acetate Oral Suspension
Mercaptopurine Oral Suspension II (Paddle)
Nitazoxanide Oral Suspension II (Paddle
Nystatin Oral Suspension II (Paddle)
Oseltamivir Phosphate Oral Suspension II (Paddle)
Posaconazole Oral Suspension II (Paddle)
Oral Suspension
Sulfisoxazole Acetyl II (Paddle)
(Pediatric)
OTC Tablet (Delayed
Omeprazole Magnesium II (Paddle)
Release)
OTC Tablet (Delayed
Omeprazole II (Paddle)
Release)
Omeprazole (Orally OTC Tablet (Delayed II (Paddle)
Disintegrating) Release)
Ciprofloxacin
Otic Suspension
HCl/Hydrocortisone
Ciprofloxacin/Dexamethasone Otic Suspension
Finafloxacin Otic Suspension
Testosterone Pellet Implant
Ledipasvir/Sofosbuvir Pellets II (Paddle)
Sofosbuvir Pellets II (Paddle)
Ritonavir Powder I (Basket -100 mesh)
Sodium Phenylbutyrate Powder for Oral II (Paddle)
Tenofovir Disoproxil Fumarate Powder for Oral II (Paddle)
Diclofenac Potassium Powder for Oral Solution II (Paddle
Nelfinavir Mesylate Powder for Suspension II (Paddle)
Powder for Suspension
Methylphenidate HCl II (Paddle)
Omeprazole Sodium (Extended
Powder Release)
for suspension
Bicarbonate (Immediate Release) II (Paddle)
Mesalamine Enema Rectal Enema II (Paddle)
Indomethacin Rectal Suppository

I (Suppository, dissolution
Prochlorperazine Rectal Suppository
baskets, palmieri type)

Promethazine HCl Rectal Suppository


Bupivacaine Solution (Extended II (Paddle)
Release), Infiltration
Acetaminophen Suppository II (Paddle)

Mesalamine Suppository II (Paddle) with option to use


a sinker
Miconazole Nitrate Suppository (Vaginal) I (Basket)

Terconazole Suppository (Vaginal) I (with Palmieri type basket)

Acyclovir Suspension II (Paddle)


Amoxicillin/Clavulanate
Suspension II (Paddle)
Potassium
Carbamazepine Suspension II (Paddle)
Cefadroxil Suspension II (Paddle)
Cefdinir Suspension II (Paddle)
Cefixime Suspension II (Paddle)
Cefpodoxime Proxetil Suspension II (Paddle)
Cefprozil Monohydrate Suspension II (Paddle)
Ceftibuten Dihydrate Suspension II (Paddle)
Cephalexin Suspension II (Paddle)
Chlorothiazide Suspension
Clarithromycin Suspension II (Paddle)
Clozapine Suspension II (Paddle)
Doxycycline Suspension II (Paddle)
Edaravone Suspension II (Paddle)
Eltrombopag Olamine Suspension II (Paddle)
Erythromycin Ethylsuccinate Suspension II (Paddle)
Famotidine Suspension II (Paddle)
Felbamate Suspension II (Paddle)
Fexofenadine HCl Suspension II (Paddle)
Fluconazole (200 mg/5 mL) Suspension II (Paddle)
Fluconazole (50 mg/5 mL) Suspension II (Paddle)
Hydroxyzine Pamoate Suspension
Ibuprofen Suspension
Ibuprofen/Pseudoephedrine
Suspension II (Paddle)
HCl
Linezolid Suspension II (Paddle)
Meloxicam Suspension II (Paddle)
Mycophenolate Mofetil Suspension II (Paddle)
Naproxen Suspension
Nevirapine Suspension II (Paddle)
Nitisinone Suspension II (Paddle)
Nitrofurantoin Suspension II (Paddle)
Oxcarbazepine Suspension II (Paddle)
Paroxetine HCl Suspension II (Paddle)
Perampanel Suspension II (Paddle)
Phenytoin Suspension
Riluzole Suspension II (Paddle)
Rufinamide Suspension II (Paddle)
Sildenafil Citrate Suspension II (Paddle)
Simvastatin Suspension II (Paddle)
Solifenacin Succinate Suspension II (Paddle)
Sucralfate Suspension II (Paddle)
Sulfamethoxazole/
Suspension II (Paddle)
Trimethoprim
Voriconazole Suspension II (Paddle)
Carbidopa/Levodopa Suspension (Enteral) II (Paddle)
Azithromycin Suspension (Extended II (Paddle)
Release)
Chlorpheniramine Polistirex/ Suspension (Extended
II (Paddle)
Codeine polistirex Release)
Suspension (Extended
Dextromethorphan Polistirex II (Paddle)
Release)
Suspension (Extended
Carbinoxamine Maleate II (Paddle)
Release)
Suspension (Extended
Amphetamine
Release)
Doxycycline Calcium Suspension
Exenatide Synthetic (2 Suspension, Extended
mg/0.85 mL) Release
Ibuprofen Suspension/Drop II (Paddle)
Abacavir Sulfate Tablet
Abacavir Sulfate/Dolutegravir
Tablet II (Paddle)
Sodium/Lamivudine
Abacavir Sulfate/Lamivudine
Abacavir Tablet II (Paddle)
Sulfate/Lamivudine/Zidovudin Tablet II (Paddle)
e
Abemaciclib Tablet II (Paddle)
Abiraterone Acetate Tablet II (Paddle)
Acarbose Tablet II (Paddle)
Acarbose Tablet
Acetaminophen/Aspirin/
Tablet
Caffeine
Acetaminophen/Butalbital Tablet II (Paddle)
Acetaminophen/Butalbital/
Tablet
Caffeine
Acetaminophen/Caffeine/
Tablet II (Paddle)
Dihydrocodeine Bitartrate
Acetaminophen/
Tablet
Hydrocodone Bitartrate
Acetaminophen/Ibuprofen Tablet II (Paddle)
Acetaminophen/Oxycodone Tablet
Acetaminophen/Pentazocine
Tablet I (Basket)
HCl
Acetaminophen/
Tablet
Propoxyphene
Acetaminophen/ HCl
Tablet
Propoxyphene Napsylate
Acetaminophen/Tramadol
Tablet II (Paddle)
HCl
Acetazolomide Tablet
Acyclovir Tablet
Adefovir Dipivoxil Tablet
Afatinib Dimaleate Tablet
Albuterol Sulfate Tablet
Alendronate Sodium Tablet
Alendronate
Sodium/Cholecalciferol Tablet II (Paddle)

AliskirenAliskiren
Hemifumarate Tablet
Hemifumarate/Amlodipine Tablet I (Basket)
Besylate
Aliskiren
Hemifumarate/Amlodipine Tablet I (Basket)
Besylate/Hydrochlorothiazide
Aliskiren
Hemifumarate/Hydrochloroth Tablet I (Basket)
iazide
Allopurinol Tablet
Almotriptan Malate Tablet
Alogliptin Benzoate Tablet
Alogliptin Benzoate/ Tablet II (Paddle)
Metformin HCl
Alosetron HCl Tablet
Alprazolam Tablet
Amantadine HCl Tablet
Ambrisentan Tablet II (Paddle)
Amifampridine Tablet
Amifampridine Phosphate Tablet
Amiloride HCl Tablet
Amiloride
Tablet
HCl/Hydrochlorothiazide
Aminocaproic Acid Tablet
Amiodarone HCl (Test 1) Tablet II (Paddle)
Amiodarone HCl (Test 2) Tablet I (Basket)
Amitriptyline HCl Tablet
Amlodipine Besylate Tablet
Amlodipine
Amlodipine Calcium Tablet II (Paddle)
Besylate/Atorvastatin
Besylate/Olmesartan Tablet II (Paddle)
Medoxomil
Amlodipine
Tablet II (Paddle)
Besylate/Telmisartan
Amoxicillin Tablet
Amphetamine
Aspartate/Amphetamine
Sulfate/Dextroamphetamine Tablet I (Basket)
Saccharate/Dextroamphetami
ne Sulfate
Anastrozole Tablet
Apalutamide Tablet II (Paddle)
Apixaban Tablet II (Paddle)
Apremilast Tablet II (Paddle)
Armodafinil Tablet II (Paddle)
Aspirin/Butalbital/Caffeine Tablet
Aspirin/Caffeine/
Tablet I (Basket)
Orphenadrine Citrate
Aspirin/Hydrocodone
Tablet II (Paddle)
Bitartrate
Aspirin/Meprobamate Tablet I (Basket)
Aspirin/Methocarbamol Tablet II (Paddle)
Aspirin/Oxycodone HCl Tablet
Atazanavir Sulfate/ Cobicistat Tablet II (Paddle)
Atorvastatin Calcium Tablet II (Paddle)
II (Paddle), with option to use
Atorvastatin
Tablet a sinker for 20/10 mg
Calcium/Ezetimibe
strength
Atovaquone Tablet II (Paddle)

Atovaquone/Proguanil HCl Tablet II (Paddle) with PEAK vessels

Avapritinib Tablet II (Paddle)


Azathioprine Tablet
Azilsartan Kamedoxomil Tablet II (Paddle)
Azilsartan
Tablet II (Paddle)
Kamedoxomil/Chlorthalidone
Baclofen Tablet
Baloxavir Marboxil Tablet II (Paddle)
Balsalazide Disodium Tablet II (Paddle)
Bempedoic Acid Tablet II (Paddle)
Bempedoic Acid/Ezetimibe Tablet II (Paddle)
Benazepril HCl Tablet II (Paddle)
Benazepril
Tablet I (Basket)
HCl/Hydrochlorothiazide
Bendroflumethiazide/Nadolol Tablet
Benzphetamine HCl Tablet
Bepridil HCl Tablet I (Basket)
Bethanechol Chloride Tablet
Bethanechol Chloride Tablet
Bicalutamide Tablet II (Paddle)
Bisoprolol Fumarate
Bisoprolol Tablet
Fumarate/Hydrochlorothiazid Tablet II (Paddle)
e
Bosentan Tablet II (Paddle)
Brexpiprazole Tablet II (Paddle)
Brigatinib Tablet II (Paddle)
Bromocriptine Mesylate Tablet
Bumetanide Tablet
Buspirone Hydrochloride Tablet
Busulfan Tablet
Busulfan Tablet II (Paddle)
Cabergoline Tablet
Cabotegravir Sodium Tablet II (Paddle)
Calcium Acetate Tablet
Calcium Acetate Tablet
Canagliflozin Tablet II (Paddle)

Canagliflozin/Metformin HCl Tablet II (Paddle)


Candesartan Cilexetil (16 mg,
Tablet II (Paddle)
8 mg and 4 mg)
Candesartan Cilexetil (32 mg)
Candesartan Tablet II (Paddle)
Cilexetil/Hydrochlorothiazide Tablet II (Paddle)
(16/12.5 mg)
Candesartan
Cilexetil/Hydrochlorothiazide Tablet II (Paddle)
(32/12.5 mg and 32/25 mg)
Capecitabine Tablet
Capecitabine Tablet
Capmatinib HCl Tablet I (Basket)
Captopril Tablet
Carbidopa/Entacapone/
Tablet I (Basket)
Levodopa
Carbidopa/Levodopa Tablet
Carbinoxamine Maleate Tablet
Carisoprodol Tablet
Carvedilol Tablet
Carvedilol Tablet II (Paddle)
Cedazuridine/Decitabine Tablet II (Paddle)
Cefadroxil Tablet
Cefditoren Pivoxil Tablet II (Paddle)
Cefpodoxime Proxetil Tablet
Cefprozil Tablet
Cefprozil Tablet
Cefuroxime Axetil Tablet
Cenobamate Tablet II (Paddle)
Ceritinib Tablet I (Basket)
Chlorambucil Tablet II (Paddle)
Chloroquine Phosphate
Chlorpheniramine Tablet
Maleate/Ibuprofen/Phenylep
Chlorpheniramine Tablet II (Paddle)
hrine HCl
Maleate/Ibuprofen/Pseudoep Tablet II (Paddle)
hedrine HCl
Chlorthalidone Tablet
Chlorzoxazone Tablet
Cilostazol Tablet II (Paddle)
Cinacalcet HCl Tablet II (Paddle)
Ciprofloxacin HCl Tablet
Citalopram HBr Tablet
Cladribine Tablet II (Paddle)
Clarithromycin Tablet
Clobazam Tablet II (Paddle)
Clonazepam Tablet
Clonidine HCl Tablet
Clopidogrel Bisulfate Tablet
Clorazepate Dipotassium Tablet
Cobicistat Tablet II (Paddle)
Cobicistat (Cobi)/ Darunavir Cobi: II (Paddle): Drv: II
Ethanolate (Drv) Tablet (Paddle)
Cobicistat/Elvitegravir/
Emtricitabine/Tenofovir Tablet II (Paddle)
Alafenamide Fumarate
Colchicine Tablet
Colchicine Tablet

Colesevelam HCl Tablet

Cyclobenzaprine HCl Tablet


Cyclophosphamide Tablet I (Basket)
Cyproheptadine HCl Tablet
Dapagliflozin Propanediol Tablet
Dapagliflozin/Saxagliptin HCl Tablet
Darolutamide Tablet II (Paddle)
Darunavir Ethanolate Tablet II (Paddle)
Darunavir(Drv)/Cobicistat
(Cobi)/Emtricitabine
Tablet II (Paddle)
(Emt)/Tenofovir Alafenamide
Fumarate (Taf)
Dasatinib Tablet II (Paddle)
Deferiprone Tablet
Deferiprone (1 GM) Tablet I (Basket)
Delafloxacin Meglumine Tablet II (Paddle)
Delavirdine Mesylate Tablet II (Paddle)
Demeclocycline HCl Tablet
Desipramine HCl Tablet
Desloratadine Tablet
Desmopressin Acetate Tablet
Desogestrel/Ethinyl Estradiol Tablet
II (Paddle) over a disk (62 mm
Deutetrabenazine Tablet with 16 mesh)
Dexamethasone Tablet
Dexmethylphenidate HCl Tablet
Dextroamphetamine Sulfate Tablet
Dextroamphetamine Sulfate Tablet I (Basket)
Diazepam Tablet
Diclofenac Potassium Tablet II (Paddle)
Dicyclomine Hydrochloride Tablet
Dienogest/Estradiol Valerate Tablet II (Paddle)
Diflunisal Tablet
Digoxin Tablet
Diphenhydramine
Tablet II (Paddle)
Citrate/Ibuprofen
Dipyridamole Tablet
Disulfiram Tablet II (Paddle)
Dolasetron Mesylate Tablet
Dolutegravir Na/Rilpivirine
Tablet II (Paddle)
HCl
Dolutegravir Sodium (10 mg) Tablet II (Paddle)
Dolutegravir Sodium (25 mg) Tablet II (Paddle)
Dolutegravir Sodium (50 mg) Tablet II (Paddle)
Doxazosin Mesylate Tablet II (Paddle)
Doxepin HCl Tablet II (Paddle)
Doxepin HCl Tablet
Doxycycline Hyclate ( 150 mg
and 75 mg) Tablet
Dronedarone HCl Tablet II (Paddle) with sinker
Drospirenone/Estradiol Tablet II (Paddle)
Efavirenz Tablet II (Paddle)
Efavirenz 600 mg;
Emtricitabine 200 mg;
Tenofovir Disoproxil Fumarate Tablet II (Paddle)
300 mg
Efavirenz/Lamivudine/ Tablet II (Paddle)
Tenofovir Disoproxil Fumarate
Elagolix Sodium Tablet II (Paddle)
Eletriptan Hydrobromide Tablet I (Basket)
Eltrombopag Olamine Tablet II (Paddle)

Elvitegravir Tablet II (Paddle) with sinker

Empagliflozin Tablet
Empagliflozin/Linagliptin Tablet II (Paddle)
Emtricitabine/Tenofovir Tablet II (Paddle)
Disoproxil Fumarate
Enalapril Maleate Tablet
Entacapone Tablet II (Paddle)
Entecavir Tablet
Enzalutamide Tablet II (Paddle)
Eplerenone Tablet
Eprosartan Mesylate
Eprosartan Tablet II (Paddle)
Mesylate/Hydrochlorothiazid Tablet II (Paddle)
e HCl
Erlotinib Tablet II (Paddle)
Erythromycin Tablet
Erythromycin Ethylsuccinate Tablet
Escitalopram Oxalate Tablet
Eslicarbazepine Acetate Tablet II (Paddle)
Estazolam Tablet II (Paddle)
Esterified Estrogens Tablet II (Paddle)
Estradiol/Norgestimate
Tablet II (Paddle)
(1mg/0.09mg)
Estrogens Conjugated
Estrogens, Conjugated Tablet I (Basket)
Synthetic A
(EC)/Medroxyprogesterone Tablet II (Paddle) with sinker
Estrogens,
AcetateConjugated
(MPA) Tablet II (Paddle)
Synthetic B
Eszopiclone Tablet
Ethambutol HCl Tablet
Ethinyl Estradiol/Ethynodiol
Tablet II (Paddle)
Diacetate
Ethinyl
Tablet
Estradiol/Levonorgestrel
Ethinyl
Ethinyl Tablet
Estradiol/Levonorgestrel (AB)
Estradiol/Levonorgestrel Tablet
Ethinyl
(AB2)
Ethinyl Tablet
Estradiol/Norethindrone
Estradiol/Norethindrone Tablet
Ethinyl
Acetate Tablet II (Paddle)
Estradiol/Norgestimate
Ethinyl
Tablet II (Paddle)
Estradiol/Norgestimate (AB)
Ethinyl Estradiol/Norgestrel Tablet II (Paddle)
Ethionamide Tablet I (Basket)
Etidronate Disodium Tablet
Etodolac Tablet
Everolimus Tablet II (Paddle)
Exemestane Tablet I (Basket)
Ezetimibe Tablet II (Paddle)
Ezetimibe/Simvastatin Tablet II (Paddle)
Famciclovir Tablet
Famotidine Tablet
Felbamate Tablet
Fenofibric Acid Tablet II (Paddle)
Ferric Citrate Tablet II (Paddle)
Fexofenadine HCl Tablet II (Paddle)
Finasteride Tablet
Finerenone Tablet II (Paddle)
Flavoxate HCl Tablet I (Basket)
Flecainide Acetate Tablet
Fluconazole Tablet
Fludarabine Phosphate Tablet II (Paddle)
Fludrocortisone Acetate Tablet
Fluphenazine HCl Tablet
Fluvoxamine Maleate Tablet
Fosamprenavir Calcium Tablet II (Paddle)
Fosinopril Sodium Tablet II (Paddle)
Fosinopril
Tablet
Sodium/Hydrochlorothiazide
Frovatriptan succinate Tablet
Furosemide Tablet
Gabapentin Tablet
Galantamine HBr Tablet
Galantamine HBr Tablet
Gefitinib Tablet II (Paddle)
Gemfibrozil Tablet
Gemifloxacin Mesylate Tablet II (Paddle)
Gilteritinib Fumarate Tablet II (Paddle)
Glimepiride Tablet II (Paddle)

Glimepiride/Pioglitazone HCl Tablet II (Paddle)


Glimepiride/Rosiglitazone
Tablet II (Paddle)
Maleate
Glipizide Tablet
Glipizide/Metformin HCL Tablet
Glyburide (Micronized) Tablet II (Paddle)
Glyburide (Non-micronized) Tablet II (Paddle)
Glyburide/Metformin HCl Tablet
Glycopyrrolate Tablet
Granisetron HCl Tablet
Griseofulvin (Microcrystalline) Tablet
Griseofulvin
(Ultramicrocrystalline) Tablet
Guanfacine HCl Tablet
Haloperidol
Homatropine Tablet
Methylbromide/Hydrocodone Tablet
BitartrateHCl
Hydralazine Tablet
Hydrochlorothiazide Tablet
Hydrochlorothiazide/ Tablet II (Paddle)
Irbesartan
Hydrochlorothiazide/Lisinopril Tablet II (Paddle)
Hydrochlorothiazide/Losartan Tablet I (Basket)
Potassium
Hydrochlorothiazide/
Tablet II (Paddle)
Moexipril HCl
Hydrochlorothiazide/
Tablet II (Paddle)
Olmesartan Medoxomil
Hydrochlorothiazide/
Tablet I (Basket)
Quinapril HCl
Hydrochlorothiazide/ Tablet
Spironolactone
Hydrochlorothiazide/ Tablet
Triamterene
Hydrocodone Tablet II (Paddle)
Bitartrate/Ibuprofen
Hydrocortisone Tablet
Hydromorphone HCl Tablet
Hydroxychloroquine Sulfate Tablet
Hydroxyurea Tablet
Hydroxyzine HCl Tablet
Ibandronate Sodium Tablet
Ibrexafungerp Citrate Tablet II (Paddle)
Ibrutinib (140 and 280 mg) Tablet II (Paddle)
Ibrutinib (420 and 560 mg) Tablet II (Paddle)
Ibuprofen Tablet
Ibuprofen/Oxycodone HCl Tablet I (Basket)
Idelalisib Tablet II (Paddle)
Iloperidone Tablet II (Paddle)
Imipramine HCl Tablet
Indapamide Tablet
Irbesartan Tablet
Isocarboxazid Tablet II (Paddle)
Isoniazid Tablet
Isosorbide Dinitrate Tablet
Isosorbide
Tablet
Dinitrate/Hydralazine HCl
Isosorbide Mononitrate Tablet II (Paddle)
Istradefylline Tablet II (Paddle) with Sinker
Ivabradine HCl Tablet
Ivacaftor Tablet II (Paddle) with sinker
Lumacaftor: II (Paddle);
Ivacaftor/lumacaftor Tablet
Ivacaftor: II (Paddle)
Ivermectin Tablet II (Paddle)
Ivosidenib Tablet II (Paddle)
Ketoconazole Tablet I (Basket)
Ketoprofen Tablet II (Paddle)
Ketorolac Tromethamine Tablet
Labetalol HCl Tablet
Lacosamide Tablet
Lamivudine Tablet
Lamivudine 150
mg/Zidovudine 300mg
Tablets and Abacavir Sulfate Tablet II (Paddle)
300 mg Tablets-co-packaged
Lamivudine/Raltegravir Ka Tablet II (Paddle)
Lamivudine/Stavudine/ Tablet II (Paddle)
Nevirapine
Lamivudine/Zidovudine Tablet
Lamivudine/Zidovudine/
Tablet II (Paddle)
Nevirapine
Lapatinib Ditosylate Tablet II (Paddle)
Lasmiditan Succinate Tablet
Ledipasvir/Sofosbuvir Tablet II (Paddle)
Lefamulin Acetate Tablet II (Paddle)
Leflunomide Tablet II (Paddle)
Leflunomide (100 mg) Tablet II (Paddle)
Lemborexant Tablet II (Paddle)
Letermovir Tablet II (Paddle)
Letrozole Tablet
Leucovorin Calcium Tablet
Levetiracetam Tablet
Levocarnitine Tablet
Levocetirizine Dihydrochloride Tablet
Levonorgestrel Tablet II (Paddle)
Levorphanol Tartrate Tablet
Levothyroxine Sodium Tablet
Linagliptin/Metformin HCl Tablet II (Paddle)
Linezolid Tablet
Liothyronine Sodium Tablet
Lisinopril Tablet
Lithium Carbonate Tablet
Lomefloxacin HCl Tablet II (Paddle)
Loperamide HCl Tablet
Loperamide HCl/Simethicone Tablet II (Paddle)
Lorazepam Tablet

Lurasidone HCl Tablet II (Paddle)

Macitentan
Magnesium Tablet II (Paddle)
Sulfate/Potassium Tablet II (Paddle)
Chloride/Sodium
Maraviroc Sulfate Tablet
Maribavir Tablet II (Paddle)
Mecamylamine HCl Tablet
Meclizine HCl Tablet I (Basket)
Medroxyprogesterone
Tablet
Acetate
Mefloquine HCl Tablet I (Basket)
Meloxicam Tablet II (Paddle)
Melphalan Tablet
Memantine HCl Tablet
Meprobamate Tablet
Meprobamate Tablet
Mercaptopurine Tablet II (Paddle)
Mesna Tablet II (Paddle)
Mestranol/Norethindrone Tablet
Metaxalone Tablet
Metformin HCl Tablet
Metformin HCl/Pioglitazone
Tablet II (Paddle)
Metformin HCl
HCl/Sitagliptin
Tablet II (Paddle)
Phosphate
Metformin/Repaglinide Tablet II (Paddle)
Methadone HCl Tablet
Methazolamide Tablet II (Paddle)
Methimazole Tablet
Methotrexate Sodium Tablet
Methscopolamine Bromide Tablet
Methylnaltrexone Bromide Tablet
Methylphenidate HCl Tablet
Methylprednisolone Tablet
Methyltestosterone Tablet II (Paddle)
Metoclopramide HCl Tablet
Metolazone Tablet
Metoprolol Tartrate Tablet
Metronidazole Tablet
Midodrine HCl Tablet
Mifepristone Tablet II (Paddle)
Milnacipran HCl Tablet
Minocycline HCl Tablet
Minoxidil Tablet
Mirtazapine Tablet
Misoprostol Tablet II (Paddle)
Mitotane Tablet
Modafinil Tablet II (Paddle)
Moexipril HCl Tablet
Molindone HCl Tablet
Montelukast Sodium Tablet II (Paddle)
Morphine Sulfate Tablet
Moxifloxacin Tablet
Mycophenolate Mofetil Tablet II (Paddle)
Nabumetone Tablet
Nadolol Tablet
Naldemedine Tablet
Naloxegol Oxalate Tablet
Naltrexone HCl Tablet
Naproxen Tablet
Naproxen Sodium
Naproxen Tablet
Sodium/Diphenhydramine
Naproxen Tablet II (Paddle)
HCl
Sodium/Diphenhydramine Tablet II (Paddle)
Naproxen
HCl
Sodium/Sumatriptan Tablet I (Basket)
SuccinateHCl
Naratriptan Tablet
Nateglinide Tablet II (Paddle)
Nebivolol HCl Tablet II (Paddle)
Nebivolol/Valsartan Tablet I (Basket)
Nefazodone HCl Tablet II (Paddle)
Nelfinavir Mesylate Tablet II (Paddle)
Neomycin Sulfate Tablet II (Paddle)
Nevirapine Tablet
Nifurtimox Tablet II (Paddle)
Nifurtimox Tablet II (Paddle)
Nilutamide Tablet
Nitazoxanide Tablet II (Paddle)
Nitisinone Tablet II (Paddle)
Norethindrone Tablet
Norethindrone Acetate Tablet
Nystatin Tablet II (Paddle)
Obeticholic Acid Tablet II (Paddle)
Ofloxacin Tablet
Olanzapine Tablet
Olmesartan Medoxomil Tablet
Ombitasvir/ Paritaprevir/
Ritonavir and Dasabuvir Tablet II (Paddle)
Sodium
Ondansetron HCl Tablet
Osilodrostat Phosphate Tablet
Osimertinib Mesylate Tablet
Ospemifene Tablet II (Paddle)
Oxandrolone Tablet
Oxcarbazepine (150 mg) Tablet II (Paddle)
Oxcarbazepine (300 mg) Tablet II (Paddle)
Oxcarbazepine (600 mg) Tablet II (Paddle)
Oxycodone HCl Tablet
Palbociclib Tablet II (Paddle)
Pancrelipase Tablet II (Paddle)
Paroxetine HCl Tablet
Paroxetine Mesylate Tablet
Pazopanib HCl Tablet II (Paddle)
Pemigatinib Tablet I (Basket)
Pemoline Tablet II (Paddle)
Penbutolol Sulfate Tablet
Perampanel Tablet II (Paddle)
Pergolide Mesylate Tablet II (Paddle)
Perindopril Erbumine Tablet II (Paddle)
Perphenazine Tablet
Phendimetrazine Tartrate Tablet
Phenelzine Sulfate Tablet II (Paddle)
Phentermine HCl Tablet
Phytonadione Tablet
Pilocarpine HCl Tablet
Pimozide Tablet
Pindolol Tablet
Pioglitazone HCl Tablet II (Paddle)
Pirfenidone Tablet
Ponatinib HCl Tablet I (Basket)
Potassium Citrate Tablet
Pramipexole Dihydrochloride Tablet
Pravastatin Sodium Tablet
Praziquantel Tablet
Prednisolone Tablet
Prednisone Tablet
Pretomanid Tablet II (Paddle)
Primaquine Phosphate Tablet
Primidone Tablet
Prochlorperazine Maleate Tablet II (Paddle)
Promethazine HCl Tablet
Propafenone HCl Tablet
Propranolol HCl Tablet
Propylthiouracil Tablet
Protriptyline HCl Tablet
Protriptyline HCl Tablet
Prucalopride Succinate Tablet
Pseudoephedrine
Tablet
HCl/Triprolidine HCl
Pyrazinamide Tablet
Pyridostigmine Bromide Tablet
Pyrimethamine Tablet
Quetiapine Fumarate Tablet II (Paddle)
Quinapril HCl Tablet
Raloxifene HCl Tablet II (Paddle)
II (Paddle) with option to use
Raltegravir Potassium Tablet
a sinker
Ramelteon Tablet
Ramipril Tablet
Ranitidine HCl Tablet
Rasagiline Mesylate Tablet
Regorafenib Tablet II (Paddle)
Relugolix Tablet II (Paddle)
Repaglinide Tablet
Ribavirin Tablet II (Paddle)
Ribociclib Tablet II (Paddle)
Rifapentine Tablet II (Paddle)
Riluzole Tablet II (Paddle)
Rimantadine HCl Tablet II (Paddle)
Riociguat Tablet II (Paddle)
Ripretinib Tablet II (Paddle)
Risedronate Sodium Tablet
Risperidone Tablet II (Paddle)
Ritonavir Tablet
Rizatriptan Benzoate Tablet
Rolapitant HCl Tablet II (Paddle)
Ropinirole HCl Tablet
Rosuvastatin Calcium Tablet
Ruxolitinib Phosphate Tablet
Safinamide Mesylate Tablet II (Paddle)
Sapropterin Dihydrochloride Tablet
Saquinavir Mesylate Tablet II (Paddle)
Selinexor Tablet II (Paddle)
Semaglutide Tablet II (Paddle)
Sertraline HCl Tablet II (Paddle)
Sevelamer Carbonate Tablet
Sevelamer HCl Tablet
Sildenafil Citrate Tablet I (Basket)
Simvastatin Tablet
Siponimod Fumaric Acid Tablet II (Paddle)
Sirolimus Tablet Basket (20 mesh)
Sitagliptin Phosphate Tablet

II (Paddle) with stainless steel


Sitagliptin Tablet stationary quadrangular
Phosphate/Simvastatin
hanging basket
Sodium Phosphate Dibasic
Anhydrous/Sodium
Tablet II (Paddle)
Phosphate Monobasic
Monohydrate
Sofosbuvir Tablet II (Paddle)
Sofosbuvir/Velpatasvir Tablet II (Paddle)
Solifenacin Succinate Tablet
Solriamfetol HCl Tablet I (Basket)
Sorafenib Tosylate Tablet II (Paddle)
Spironolactone Tablet
Sucralfate Tablet II (Paddle)
Sulfadiazine Tablet
Sulfamethoxazole/
Tablet
Trimethoprim
Sulfasalazine Tablet
Sumatriptan Succinate Tablet
Suvorexant Tablet II (Paddle) with sinker
Tadalafil Tablet II (Paddle)
Tafenoquine Succinate Tablet II (Paddle)
Tamoxifen Citrate Tablet
Tapentadol HCl Tablet
Tazemetostat Hydrobromide Tablet II (Paddle)
Tedizolid Phosphate Tablet II (Paddle)
Tegaserod Maleate Tablet II (Paddle)
Telaprevir Tablet II (Paddle)
Telbivudine Tablet II (Paddle)
Telithromycin Tablet II (Paddle)
Tenapanor Hydrochloride Tablet II (Paddle)
Tenofovir Disoproxil Fumarate Tablet II (Paddle)
Terazosin HCl Tablet II (Paddle)
Terbinafine HCl Tablet II (Paddle)
Teriflunomide Tablet II (Paddle)
Tetrabenazine Tablet II (Paddle)
Tetracycline HCl Tablet
Thioguanine Tablet
Tiagabine HCl Tablet
Ticagrelor Tablet II (Paddle)
Ticlopidine HCl Tablet II (Paddle)
Timolol Maleate Tablet
Tinidazole Tablet
Tipiracil HCl/Trifluridine Tablet II (Paddle)
Tizanidine HCl Tablet
Tofacitinib Citrate Tablet
Tolcapone Tablet
Tolterodine Tartrate Tablet
Tolvaptan Tablet II (Paddle)
Topiramate Tablet
Toremifene Citrate Tablet II (Paddle)
Torsemide Tablet II (Paddle)
Torsemide [20, 40 and 60 mg] Tablet II (Paddle)
Tramadol HCl Tablet
Trametinib Dimethyl Sulfoxide Tablet II (Paddle)
Trandolapril Tablet II (Paddle)
Tranylcypromine Sulfate Tablet
Trazodone HCl Tablet
Triclabendazole Tablet II (Paddle)
Trimethoprim Tablet
Trospium Chloride Tablet
Tucatinib Tablet II (Paddle)
Ulipristal Acetate Tablet II (Paddle)
Ursodiol Tablet
Valacyclovir Hydrochloride Tablet
Valganciclovir HCl Tablet
Vandetanib Tablet II (Paddle)
Vardenafil HCl Tablet
Varenicline Tartrate Tablet
Vemurafenib Tablet II (Paddle)
Venlafaxine HCl Tablet
Verapamil HCl Tablet
Vericiguat Tablet II (Paddle)
Vibegron Tablet
Vigabatrin Tablet
Vilazodone HCl Tablet II (Paddle)
Vorapaxar Sulfate Tablet II (Paddle)
Voriconazole Tablet II (Paddle)
Vortioxetine HBr Tablet II (Paddle)
Voxelotor Tablet II (Paddle)
Warfarin Sodium Tablet
Zafirlukast Tablet II (Paddle)
Zalcitabine Tablet
Zidovudine Tablet
Zileuton Tablet II (Paddle)
Zolmitriptan Tablet
Zolpidem Tartrate Tablet
Acyclovir Tablet (Buccal) I (Basket)
Fentanyl Citrate (0.1 mg and II (Paddle) small volume
Tablet (Buccal)
0.4 mg) dissolution apparatus
Fentanyl Citrate (0.2 mg, 0.3 II (Paddle) small volume
Tablet (Buccal)
mg, 0.6 mg and 0.8 mg) dissolution apparatus
Miconazole Tablet (Buccal) I (Basket)
Tablet (Chewable
Lamotrigine II (Paddle)
dispersible)
Albendazole
Aluminum Tablet (Chewable) II (Paddle)
Hydroxide/Magnesium Tablet (Chewable)
Amoxicillin/Clavulanate
Trisilicate Tablet (Chewable)
Potassium
Amoxicillin/Clavulanate
Tablet (Chewable) II (Paddle)
Potassium
Carbamazepine Tablet (Chewable) II (Paddle
Cefixime Tablet (Chewable) II (Paddle
Didanosine Tablet (Chewable) II (Paddle)
Ethinyl
Tablet (Chewable) II (Paddle)
Estradiol/Norethindrone
Estradiol/Norethindrone
Ethinyl Tablet (Chewable) II (Paddle)
Acetate [0.01mg,0.01 mg;1
Estradiol/Norethindrone Tablet (Chewable) II (Paddle)
Acetate [0.02mg;1mg]
Famotidine Tablet (Chewable) II (Paddle)
Famotidine/Calcium
Carbonate/Magnesium Tablet (Chewable)
Hydroxide
Ibuprofen Tablet (Chewable) II (Paddle)
Loperamide HCl Tablet (Chewable) II (Paddle)
Loperamide HCl/Simethicone Tablet (Chewable) II (Paddle)
Loratadine
Magnesium Tablet (Chewable) II (paddle)
Hydroxide/Omeprazole/Sodiu
Magnesium Tablet (Chewable) II (Paddle)
m Bicarbonate
Hydroxide/Omeprazole/Sodiu Tablet (Chewable) II (Paddle)
m Bicarbonate
Mebendazole Tablet (Chewable) II (Paddle)
Mebendazole ( 500 mg) Tablet (Chewable) II (Paddle)
Meclizine HCl Tablet (Chewable) I (Basket)
Montelukast Sodium Tablet (Chewable) II (Paddle)
Phenytoin Tablet (Chewable)
Raltegravir Potassium Tablet (Chewable) II (Paddle)
Sucroferric Oxyhydroxide Tablet (Chewable) II (Paddle)
Cefaclor Tablet (Chewable)
Methylphenidate HCl Tablet (Chewable) I (Basket)
Lopinavir/Ritonavir Tablet (Combination)

Lamivudine/Zidovudine +
Tablet (Copackage) II (Paddle)
Efavirenz
Lamivudine/Zidovudine +
Tablet (Copackage) II (Paddle)
Nevirapine
Risedronate Sodium/Calcium
Tablet (Copackaged)
Carbonate
Acamprosate Calcium Tablet (Delayed Release) I (Basket)

Diclofenac Sodium Tablet (Delayed Release)


Diclofenac
II (Paddle) (diclo) II (Paddle)
Sodium/Misoprostol Enteric Tablet (Delayed Release) (miso)
Coated
Divalproex Sodium
Doxycycline Hyclate ( 200 mg, Tablet (Delayed Release)
150 mg, 100 mg, 80 mg and Tablet (Delayed Release)
Doxycycline75Hyclate
mg) ( 50 mg) Tablet (Delayed Release) I (Basket)
Mesalamine (1.2 gram) Tablet (Delayed Release) II (Paddle)
Mesalamine (400 mg and 800
Tablet (Delayed Release)
mg)

Mycophenolic acid Tablet (Delayed Release) II (Paddle)

Posaconazole Tablet (Delayed Release) II (Paddle)

Rabeprazole Sodium Tablet (Delayed Release) II (Paddle)

Rifamycin Sodium Tablet (Delayed Release) II (Paddle)


Tiopronin Tablet (Delayed Release) I (Basket)
Aspirin/ Omeprazole Tablet (Delayed Release) I (Basket)
Doxycycline Hyclate ( 120 mg
Tablet (Delayed Release) I (Basket)
and 60 mg)
Erythromycin Tablet (Delayed Release)
Esomeprazole Magnesium Tablet (Delayed Release) II (Paddle)
Naproxen Tablet (Delayed Release)
Pantoprazole Sodium Tablet (Delayed Release)
Prednisone Tablet (Delayed Release) II (Paddle) with sinker
Risedronate Sodium Tablet (Delayed Release) II (Paddle)
Sulfasalazine Tablet (Delayed Release)
Bisacodyl/Polyethylene glycol
3350/ Potassium Tablet (Delayed Release),
II (Paddle)
Chloride/Sodium For Solution,
Bicarbonate/ Sodium Chloride Tablet (Delayed Release,
Dexlansoprazole I (Basket -100 mesh)
Orally(Delayed
Tablet Disintegrating)
Release,
Lansoprazole II (Paddle)
Orally Disintegrating)
Chlorhexidine Gluconate Tablet (Dental)
Acetylcysteine Tablet (Effervescent)
Ranitidine HCl Tablet (Effervescent)
II (Paddle) with option to use
Tofacitinib Citrate Tablet (Extended Release)
a sinker
Tablet (Extended Release,
Amphetamine II (Paddle
Orally Disintegrating)
Fostemsavir Tromethamine Tablet (Extended Release I (Basket)
Acetaminophen/Oxycodone
Tablet (Extended Release) II (Paddle) with sinker
HCl
Albuterol Sulfate Tablet (Extended Release) II (Paddle)
Alfuzosin HCl Tablet (Extended Release) II (Paddle)
Alprazolam Tablet (Extended Release) I (Basket)
Amphetamine; Amphetamine
Aspartate/Dextroamphetamin Tablet (Extended Release) II (Paddle)
e Sulfate
Budesonide Tablet (Extended Release) II (Paddle)

Bupropion HCl Tablet (Extended Release)


Bupropion Hydrobromide Tablet (Extended Release) I (Basket)
Carbamazepine Tablet (Extended Release)
Cetirizine Tablet (Extended Release) I (Basket)
HCl/Pseudoephedrine HCl
Chlorpheniramine Maleate Tablet (Extended Release) III (Reciprocating Cylinder)

Ciprofloxacin HCl Tablet (Extended Release) I (Basket)


Ciprofloxacin/Ciprofloxacin
Tablet (Extended Release) II (Paddle)
HCl (AB)
Clarithromycin Tablet (Extended Release)
Clonidine HCl (0.1 mg & 0.2
Tablet (Extended Release) II (Paddle) with sinker
mg)
Dapagliflozin Propanediol/
Tablet (Extended Release) I (Basket- 20 mesh)
Metformin HCl

Darifenacin Hydrobromide Tablet (Extended Release) I (Basket)


Desloratadine/
Pseudoephedrine Sulfate (2.5 Tablet (Extended Release) II (Paddle)
mg/120 mg)
Desloratadine/
Pseudoephedrine Sulfate (5 Tablet (Extended Release) II (Paddle)
mg/240 mg)
Desvenlafaxine Succinate Tablet (Extended Release) I (Basket)
Dexbrompheniramine
Maleate/Pseudoephedrine Tablet (Extended Release) III (Reciprocating Cylinder)
Sulfate
Dextromethophan
HBr/Guaifenesin Tablet (Extended Release) I (Basket)
Diclofenac Sodium Tablet (Extended Release)
Diethylpropion HCl Tablet (Extended Release) I (Basket)
Diltiazem HCl Tablet (Extended Release) II (Paddle)
Doxazosin Mesylate Tablet (Extended Release) II (Paddle)
Empagliflozin/Linagliptin/
Tablet (Extended Release) I (Basket)
Metformin HCl
Felodipine Tablet (Extended Release)
Fexofenadine Tablet (Extended Release)
HCl/Pseudoephedrine HCl
Fluvastatin Sodium Tablet (Extended Release) I (Basket)
Gabapentin Enacarbil Tablet (Extended Release) II (Paddle)
Glipizide Tablet (Extended Release) II (Paddle)
Guaifenesin
Guaifenesin/ Tablet (Extended Release) I (Basket)
Pseudoephedrine Tablet (Extended Release) I (Basket)
Hydrochloride
Hydrocodone Bitartrate Tablet (Extended Release) I (Basket-10 mesh)
Isosorbide Dinitrate Tablet (Extended Release)
Isosorbide Mononitrate Tablet (Extended Release)
Isradipine (10 mg) Tablet (Extended Release) II (Paddle)
Isradipine (5 mg) Tablet (Extended Release) II (Paddle)
Levetiracetam Tablet (Extended Release) I (Basket)
Lithium Carbonate Tablet (Extended Release)
Lovastatin Tablet (Extended Release) II (Paddle)
Lovastatin/Niacin Tablet (Extended Release) I (Basket)
Metformin HCl Tablet (Extended Release)
Metoprolol Succinate Tablet (Extended Release)
Minocycline HCl (135 mg and
Tablet (Extended Release) I (Basket)
Naltrexone 105 mg)
HCl/Bupropion
Tablet (Extended Release) II (Paddle)
HCl
Nevirapine Tablet (Extended Release) I (Basket)
Niacin Tablet (Extended Release) I (Basket)
Nifedipine Tablet (Extended Release)

Nisoldipine Tablet (Extended Release) II (Paddle) with option to use


a sinker
Oxybutynin Chloride Tablet (Extended Release)
Paroxetine Tablet (Extended Release)
Pentoxifylline Tablet (Extended Release)
Potassium Chloride Tablet (Extended Release)
Pregabalin Tablet (Extended Release) II (Paddle)
Pseudoephedrine HCl Tablet (Extended Release)
Pyridostigmine Bromide Tablet (Extended Release) II (Paddle)

Quetiapine Fumarate Tablet (Extended Release) I (Basket, with 20 mesh)

Quinidine Gluconate Tablet (Extended Release)


Ranolazine Tablet (Extended Release)
Theophylline (100 mg and 200
mg) Tablet (Extended Release) II (Paddle)

Theophylline (300 mg and 450


Tablet (Extended Release) II (Paddle)
mg)
Tramadol HCl Tablet (Extended Release) I (Basket)

Trandolapril/Verapamil HCl Tablet (Extended Release) II (Paddle)

Upadacitinib Tablet (Extended Release) I (Basket)

Venlafaxine Besylate Tablet (Extended Release) II (Paddle with sinker)


Zolpidem Tartrate Tablet (Extended Release)
Acetaminophen Tablet (Extended Release)

Amoxicillin Tablet (Extended Release) II (Paddle)

Cefaclor Tablet (Extended Release)


Clonidine ( 0.1 mg) Tablet (Extended Release) II (Paddle) with sinker
Clonidine ( EQ. 0.17 mg and Tablet (Extended Release) II (Paddle)
EQ. 0.26 mg)
Dalfampridine Tablet (Extended Release) II (Paddle)
Etodolac Tablet (Extended Release)
Guanfacine Tablet (Extended Release) II (Paddle)
Hydrochlorothiazide/
Tablet (Extended Release) II (Paddle)
Metoprolol Succinate
VII (Reciprocating holder)
Hydromorphone HCl Tablet (Extended Release)
(Sample holder-Cage)
Lamotrigine Tablet (Extended Release)
Linagliptin/Metformin HCl Tablet (Extended Release) I (Basket)
Loratadine/Pseudoephedrine
Sulfate (10 mg /240 mg) Tablet (Extended Release) I (Basket)

Loratadine/Pseudoephedrine Tablet (Extended Release)


II (Paddle)
Sulfate (5 mg /120 mg)
Metformin HCl/Saxagliptin Tablet (Extended Release) I (Basket)
Methylphenidate Tablet (Extended Release)
Mirabegron Tablet (Extended Release) I (Basket)
Morphine Sulfate (AB) Tablet (Extended Release) I (Basket)
Morphine Sulfate (BC) Tablet (Extended Release) I (Basket)
Naproxen Sodium Tablet (Extended Release) II (Paddle)

Niacin: I (40 mesh rotating


Niacin/Simvastatin Tablet (Extended Release) Basket); Simvastain: I (10
mesh rotating Basket)

Orphenadrine Citrate Tablet (Extended Release)


Oxycodone HCl Tablet (Extended Release)
Oxymorphone HCl Tablet (Extended Release) II (Paddle) with sinker
Paliperidone Tablet (Extended Release) II (Paddle)
Pramipexole Dihydrochloride Tablet (Extended Release) I (Basket)
Ropinirole HCl Tablet (Extended Release) II (Paddle)
Tapentadol HCl Tablet (Extended Release) II (Paddle) with sinker
Theophylline (600 mg and 400
mg) Tablet (Extended Release) I (Basket)
Trazodone HCl Tablet (Extended Release) II (Paddle)
Treprostinil Diolamine Tablet (Extended Release) I (Basket)
Venlafaxine HCl Tablet (Extended Release) II (Paddle)
Verapamil HCl Tablet (Extended Release)

Met: I (Basket, 40 mesh):


Canagliflozin (Can)/
Tablet (Extended Release) Can: I (Basket, 10 mesh [with
Metformin HCl (Met)
option of tablet holder])

Carbidopa/Levodopa Tablet (Extended Release) II (Paddle)


Chlorpheniramine
Tablet (Extended Release) II (Paddle)
Maleate/Codeine Phosphate
Dasabuvir Na/ III (Reciprocating Cylinder [40
Ombitasvir/Paritaprevir/Riton Tablet (Extended Release) mesh (for bottom and top of
avir the inner tube)]
Divalproex Sodium Tablet (Extended Release)
Doxylamine
Tablet (Extended Release) II (Paddle)
Succinate/Pyridoxine HCl
Empagliflozin/ Metformin HCl Tablet (Extended Release) I (Basket)

Fesoterodine Fumarate Tablet (Extended Release) II (Paddle) with sinker


Lorcaserin HCl Tablet (Extended Release) I (Basket)
Morphine Sulfate Tablet (Extended Release) I (Basket)
Oxcarbazepine Tablet (Extended Release) II (Paddle) with sinker
Oxycodone HCl/ Naloxone HCl Tablet (Extended Release) II (Paddle)
Pentoxifylline Tablet (Extended Release)
Tacrolimus Tablet (Extended Release) II (Paddle)
Zileuton Tablet (Extended Release) II (Paddle) with sinker
Tablet (Extended Release,
Methylphenidate HCl II (Paddle)
Chewable)
Tablet (Extended Release,
Methylphenidate II (Paddle)
Orally Disintegrating )
Tablet (for Oral
Deferasirox II (Paddle)
Suspension)
Bosentan Tablet (For Suspension) II (Paddle)
Tablet (Orally
Donepezil HCl II (Paddle)
Disintegrating (ODT))
Tablet (Orally
Mirtazapine II (Paddle)
Disintegrating (ODT))
Tablet (Orally
Alprazolam II (Paddle)
Disintegrating)
Tablet (Orally
Amlodipine Besylate II (Paddle)
Disintegrating)
Tablet (Orally
Aripiprazole II (Paddle)
Disintegrating)
Tablet (Orally
Baclofen II (Paddle)
Disintegrating)
Tablet (Orally
Carbidopa/Levodopa II (Paddle)
Disintegrating)
Tablet (Orally
Clonazepam II (Paddle)
Disintegrating)
Tablet (Orally
Desloratadine II (Paddle)
Disintegrating)
Tablet (Orally
Famotidine II (Paddle)
Disintegrating)
Tablet (Orally
Fexofenadine HCl II (Paddle)
Disintegrating)
Tablet (Orally
Loratadine I (Basket)
Disintegrating)
Tablet (Orally
Metoclopramide HCl I (Basket)
Disintegrating)
Tablet (Orally
Olanzapine
Disintegrating)
Tablet (Orally
Ondansetron Disintegrating)
Prednisolone Sodium Tablet (Orally
II (Paddle)
Phosphate Disintegrating)
Tablet (Orally
Risperidone II (Paddle)
Disintegrating)
Tablet (Orally
Selegiline HCl I (Basket)
Disintegrating)
Tablet (Orally
Simvastatin II (Paddle)
Disintegrating)
Tablet (Orally
Zolmitriptan II (Paddle)
Disintegrating)
Tablet (Orally
Cetirizine HCl
Disintegrating)

Clozapine Tablet (Orally II (Paddle


Disintegrating)
Tablet (Orally
Phentermine HCl II (Paddle)
Disintegrating)
Tablet (Orally
Vardenafil HCl II (Paddle)
Disintegrating)
Tablet (Orally
Esomeprazole Magnesium Disintegrating, Delayed II (Paddle)
Release)
Cetirizine HCl Tablet (Regular &
Chewable)
Lamotrigine Tablet (Regular) II (Paddle)
Buprenorphine HCl Tablet (Sublingual) I (Basket)
Buprenorphine HCl/Naloxone
Tablet (Sublingual) I (Basket)
HCl
Fentanyl Citrate Tablet (Sublingual) II (Paddle)
Nitroglycerin Tablet (Sublingual) II (Paddle)
Sufentanil Citrate Tablet (Sublingual) II (Paddle)
Zolpidem Tartrate (1.75 and
Tablet (Sublingual) II (Paddle)
3.5 mg) (5 and 10
Zolpidem Tartrate
mg) Tablet (Sublingual) II (Paddle)
Asenapine Maleate Tablet (Sublingual) II (Paddle)
Clotrimazole Tablet (Vaginal) II (Paddle)
Acetazolamide Tablet
Albendazole Tablet
Aliskiren
Amlodipine Tablet I (Basket)
Hemifumarate/Valsartan
Besylate/Hydrochlorothiazide Tablet II (Paddle)
/Olmesartan Medoxomil
Amlodipine
Besylate/Hydrochlorothiazide Tablet
Amlodipine
/Valsartan Tablet II (Teflon coated paddle)
besylate/Perindopril
Amlodipine Arginine
Tablet
Besylate/Valsartan
Amoxicillin/Clavulanate
Tablet
Potassium
Aripiprazole Tablet
Atenolol Tablet
Atenolol/Chlorthalidone Tablet
Atropine Sulfate/
Tablet
Diphenoxylate HCl
Avanafil Tablet II (Paddle)
Axitinib Tablet II (Paddle)
Azithromycin Tablet
Bedaquiline Fumarate Tablet I (Basket)
Bosutinib Monohydrate Tablet II (Paddle)

Brivaracetam Tablet II (Paddle

Bupropion HCl Tablet


Cabozantinib S-Malate Tablet II (Paddle
Carbamazepine Tablet
Carbidopa Tablet
Carglumic Acid Tablet
Cefixime Tablet
Chlorpromazine HCl Tablet
Clomiphene Citrate Tablet
Clozapine Tablet
Cobicistat/Elvitegravir/
Emtricitabine/Tenofovir Tablet II (Paddle) with sinker
Disoproxil Fumarate
Cobimetinib Fumarate Tablet
Codeine Sulfate Tablet
Daclatasvir Dihydrochloride Tablet II (Paddle)
Dapsone Tablet
Deferasirox Tablet II (Paddle)
Donepezil HCl Tablet
Donepezil HCl (23 mg) Tablet II (Paddle
Doxycycline Hyclate Tablet
Drospirenone/Ethinyl
Drospirenone/Ethinyl Tablet
Estradiol
Estradiol/Levomefolate Tablet II (Paddle)
Calcium
Elbasvir/Grazoprevir Tablet I (Basket)
Eluxadoline Tablet
Empagliflozin/Metformin HCl Tablet II (Paddle)
Emtricitabine/Rilpivirine
HCl/Tenofovir Alafenamide Tablet II (Paddle
Fumarate
Emtricitabine/Rilpivirine
HCl/Tenofovir Disoproxil Tablet II (Paddle) with sinker
Fumarate
Emtricitabine/Tenofovir
Tablet II (Paddle
Alafenamide Fumarate
Estradiol/Norethindrone Tablet
Acetate
Ethacrynic Acid Tablet
Ethinyl Estradiol Tablet

Etravirine (200 mg) Tablet II (Paddle)

Etravirine (25 and 100 mg) Tablet II (Paddle)

Ezogabine Tablet II (Paddle)


Famotidine/Ibuprofen Tablet II (Paddle)
Febuxostat Tablet II (Paddle)
Fenofibrate (40 mg and 120
Tablet II (Paddle
Fenofibrate mg)
(48 mg and 145
Tablet II (Paddle
Fenofibrate mg)
(54 mg and 160
Tablet II (Paddle
mg)
Ferrous Fumarate Tablet
Fidaxomicin Tablet II (Paddle)
Flibanserin Tablet II (Paddle)
Fluoxetine HCl Tablet
Hydrochlorothiazide/
Metoprolol Tartrate Tablet
Hydrochlorothiazide/
Tablet
Telmisartan
Hydrochlorothiazide/ Tablet
Valsartan
Ibuprofen/Phenylephrine HCl Tablet II (Paddle)
Imatinib Mesylate Tablet II (Paddle)
Itraconazole Tablet II (Paddle)
Lesinurad Tablet II (Paddle)
Levofloxacin Tablet
Linagliptin Tablet
Lorcaserin HCl Tablet
Losartan Potassium Tablet
Methenamine Hippurate Tablet
Methocarbamol Tablet
Methylergonovine Maleate Tablet
Mifepristone [300 mg] Tablet II (Paddle)
Miglitol Tablet
Ombitasvir/Paritaprevir/
Ritonavir Tablet II (Paddle) with sinker
Oxaprozin Tablet
Penicillin V Tablet
Penicillin V Potassium Tablet
Pimavanserin Tartrate Tablet
Pitavastatin Calcium Tablet I (Basket)
Prasugrel HCl Tablet II (Paddle)
Rifaximin (200 mg) Tablet II (Paddle)
Rifaximin (550 mg) Tablet II (Paddle)
Rilpivirine HCl Tablet II (Paddle)
Rivaroxaban (10 mg) Tablet II (Paddle)
Rivaroxaban (15 and 20 mg) Tablet II (Paddle)
Rivaroxaban (2.5 mg) Tablet II (Paddle)
Roflumilast Tablet II (Paddle)
Rucaparib Tablet II (Paddle)
Rufinamide Tablet
Sacubitril/Valsartan Tablet I (Basket)
Saxagliptin HCl Tablet
Selexipag Tablet II (Paddle)
Telmisartan Tablet
Tenofovir Alafenamide
Tablet
Fumarate
Tiopronin Tablet
Tranexamic Acid Tablet II (Paddle
Valsartan Tablet

III (Reciprocating Cylinder)


Venetoclax Tablet [Bottom Screen: 200 mesh
stainless steel]

Crofelemer Tablet (Delayed Release) II (Paddle)

Naproxen/Esomeprazole
Tablet (Delayed Release) II (Paddle) with sinkers
Magnesium

Tablet, (Orally
Rimegepant Sulfate II (Paddle)
Disintegrating (ODT))
Tablet, (Orally
Rizatriptan Benzoate
Disintegrating (ODT))
Lamotrigine Tablet, For Suspension
Voxelotor Tablet, for Suspension II (Paddle)
Levetiracetam Tablet, for Suspension II (Paddle)
Elexacaftor, Ivacaftor,
Tezacaftor [FDC:ELE+ IVA+ Tablet/Tablet (Copackage) II (Paddle)
TEZ]; Ivacaftor [IVA]
Ivacaftor/Tezacaftor [FDC: II (Paddle) with option to use
Tablet/Tablet (Copackage)
IVA+ TEZ]; Ivacaftor [IVA] a sinker
Letrozole (LET); Ribociclib Tablet/Tablet (Copackage) II (Paddle)
Succinate (RIB)
Oxymorphone HCl Tablets
V (Paddle over Disk) with a
Diclofenac Epolamine Topical patch watchdish (a diameter of 6
cm)
Paddle over Disk (Apparatus
Lidocaine Topical Patch
5)
Menthol/Methyl Salicylate Topical Patch VI (Cylinder)
Ciclopirox Topical Suspension
Paddle over Disk (Apparatus
Oxybutynin Trans-dermal
5)
Asenapine Transdermal VI (Cylinder)
Clonidine Transdermal
Paddle over Disk (Apparatus
Rotigotine Transdermal
5)
Reciprocating disk
Scopolamine Transdermal
(Apparatus 7)
Selegiline (20 mg/20 cm2 and Transdermal Paddle over Disk (Apparatus
30 mg/30 cm2) 5)
Rotating Cylinder (Apparatus
Selegiline (40 mg/40 cm2) Transdermal
6)
Methylphenidate Transdermal Patch VI (Cylinder)
Ethinyl
Transdermal System V (paddle over disk)
Estradiol/Levonorgestrel

VII (Reciprocating holder)-


Fentanyl Transdermal
cylinder.

Progesterone Vaginal Insert II (Paddle)


Vaginal Insert (Extended
Dinoprostone II (Paddle)
Release)
Estradiol Vaginal Ring Incubator shaker
Ethinyl Estradiol/Etonogestrel Vaginal Ring
Dinoprostone Vaginal Suppository
Estradiol Vaginal Tablet I (Basket)
Speed (RPMs) Medium Volume (mL)
BiSub: 0.1 N HCl /Met: Refer to USP /Tet:
50 Refer to FDA's Dissolution Guidance, 900
2018
1% sodium dodecyl sulfate in double
60 1000
distilled water
Refer to FDA's Dissolution Guidance,
2018
100 Water 900
Refer to USP
50 0.01 N HCl 900
Refer to USP
Refer to USP
50 0.1 N HCl 900
Refer to FDA's Dissolution Guidance,
2018
100 0.01 N HCl 500
Refer to FDA's Dissolution Guidance,
750 ml of dilute HCl,2018
pH 1.1 for the first 2
50 hours, then add 200 ml of 200 mM 750 ml of dilute HCl, 200 ml of
phosphate buffer, and adjust to pH 6 (w/ phosphate buffer
HCl or NaOH) for the remainder
100 Water 900
50 0.1 N HCl 900
100 0.1 N HCl 900
2.2% sodium dodecyl sulfate in distilled
100 900
water
Refer to USP
Refer to USP
Refer to USP
0.01 N HCl for first hour, 0.1 M 0-1 hrs: 900 mL. 900 mL
100
Phosphate Buffer, pH 5.5, thereafter thereafter
50 0.025 N HCl 1000
Refer to FDA's Dissolution Guidance,
2018
50 Water (deaerated) 900
Refer to USP
50 pH 6.8 buffer 900
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
phosphate buffer, pH 7.5 Tier
50 2 Medium: 0.5% HDTMA in 0.05 M 900
phosphate
Tetracyclinebuffer, pH 7.5 with 0.05
and Metronidazole: 0.1g/L
N
75 HCl; Bismuth Subcitrate Potassium: 900
50 mM phosphate buffer, pH 6.8 with
Water
50 900
0.1% sodium dodecyl sulfate
Acid stage: 0.1 N HCl; Buffer stage: Acid stage: 1000; Buffer stage:
75
Phosphate Buffer, pH 7.5 1000
Develop a quantitative rupture test
Refer to FDA's Dissolution Guidance,
2018
100 Sodium Acetate Buffer, pH 5.0 (degas) 500
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
50 Phosphate Buffer, pH 6.8 900
100 0.05 M Phosphate Buffer, pH 7.2 900
Initial Medium: 750 mL of simulated
gastric fluid, USP (includes pepsin); At 20
50 mg, 100 mg and 200 mg: Tier 1: 1000 mL Tier 2: 750 mL
minutes, while stirring, add 180 mL of
50 rpm; 400 mg: 75 rpm (initial) 1000 mL (final)
appropriate concentrations of SLS
solution
Refer to(for a final
FDA's concentration
Dissolution of 1%
Guidance,
2018
60 0.01 N HCl (degassed) 900
Refer to FDA's Dissolution Guidance,
2018 individual unit
Refer to USP (provide
data).
50 0.1 N HCl 900
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
Refer to USP
75 0.1 N HCl 900

100 0.01 N HCl (pH 2.0) 900

0.2% Cetyl trimethylammonium bromide


65 900
(CTAB) in 0.1N HCl
Refer to USP
0.5% Hyamine 10X in water, adjust to pH
100 900
6.8 with 0.1 N KOH or 0.1 N HCl
Refer to USP
pH 1.2, Simulated Gastric Fluid without
100 900
enzyme
10 mM Citrate Buffer pH 5.5 with 0.05%
100 900
Sodium Dodecyl Sulfate (SDS)
50 50 mM Phosphate buffer pH 6.8 900
Refer to USP
100 200 mM Phosphate Buffer, pH 7.2 900
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
Develop a quantitative rupture test
Refer to FDA's Dissolution Guidance,
10% Labrasol in Water;
2018 (In addition, the
100 and 150 USP capsule rupture test should also be 500
Refer to FDA's Dissolution Guidance,
conducted)
bromide (CTAB)2018
in 0.1 N HCl. Tier II:
Dissolution Medium: 1% w/v CTAB in 0.1 Dutasteride: 900. Tamsulosin:
Dutasteride: 75 Tamsulosin:
N HCl with 0.16% w/v pepsin. Acid stage: 750; Buffer
50
Tamsulosin:: Acid Stage (0-2 hrs): 0.1 N stage: 1000
HCl. Buffer stage: Add 250 mL of 0.2 M

50 1% Sodium Lauryl Sulfate in water 900

Refer to FDA's Dissolution Guidance,


2018
Refer to FDA's Dissolution Guidance,
2018
50 mM Potassium Phosphate, pH 6.0
75 1000
with 0.374% w/v polysorbate 80
ammonium bromide (CTAB) in 0.1 N
50 HCl;Tier 2 Medium: 0.3% CTAB in 0.1 N 900
HCl containing Pepsin 600,000 USP
100 0.5 N NaOH with 10% Triton-X-100 500
Refer to FDA's Dissolution Guidance,
2018

3% sodium lauryl sulfate (SLS) in 0.1N HCl 250

100 Water 900


Phosphate Buffer, pH 6.8, containing
100 900
0.07%
Refer to FDA'sw/v Triton X 100
Dissolution Guidance,
2018
Refer to USP
50 0.1 N HCl 900
Phosphate Buffer w/ 2% Tween 80 and
75 900
0.1% pancreatin, pH 6.8
Refer to USP
Tier 1: KCl/HCl Buffer, pH 1.2; Tier 2:
75 1000
KCl/HCl Buffer pH 1.2, with pepsin
50 Water (deaerated) 900
0.1 N HCl with 0.2% SDS (sodium dodecyl
100 500
Refer to FDA's sulfate)
Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
50 0.1 N HCl 900
Refer to USP
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
60 Water (deaerated) 900
Refer to FDA's Dissolution Guidance,
2018
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
Refer to USP
3.0% w/v Polysorbate 20 in 50 mM
75 900
Phosphate Buffer, pH 6.8
150 Phosphate Buffer, pH 7.2 900
100 Phosphate Buffer (200 mM), pH7.2 900
Tier 1: 0.05 M phosphate buffer, pH 7.2
150 Tier 2: 0.05 M phosphate buffer, pH 7.2 900
with NMT 1750 USP protease units/L of 1
USP IV (Flow-Through Cell), and, if
X USP pancreatin
applicable, Apparatus II (Paddle) or any
other appropriate pharmacopoeial
0.1 N HCl without
apparatus, pepsin and
for comparative with 0.3%
evaluation by
pepsin (addition of pepsin is
100 900
recommended only when significant slow
dissolution is observed)
50 0.1 M Citrate Buffer, pH 3.8 900
100 10 mM citric acid buffer, pH 5.75 750
Refer to USP
Refer to USP
0.1% Lauryl Dimethylamine Oxide (LDAO)
50 500
in water
100 SGF without Enzyme 900
0.05M Potassium Phosphate Buffer, pH
50 1000
7.4
50 0.01 N HCl 900
50 50 mM Phosphate Buffer, pH 4.5 500
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018 500 mL (5 mg strength); 1000 mL
50 0.001 N HCl with 0.1% Polysorbate 80
(10 and 20 mg strength)
Develop a dissolution method
75 0.2% Sodium Lauryl Sulfate (SLS) in Water 900
Refer to FDA's Dissolution Guidance,
2018
Refer to USP
Phosphate Buffer, pH 6.1 with 0.1% 500 mL (for 5 mg); 1000 mL (for
100
Sodium Lauryl Sulfate (SLS) 10 mg)
Refer to USP
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
Polysorbate 20; Tier 2: Deionized water
50 900
with 0.5% Polysorbate 20 containing
100 0.1 N HCl 1000
Refer to FDA's Dissolution Guidance,
2018
Refer to USP
40 0.1 N HCl 900
50 0.1% Tween 80 solution 1000
75 Sodium Phosphate Buffer, pH 7.4 ± 0.05 900
Netupitant: 0.07M Phosphate buffer pH
Netupitant:100; Netupitant: 900; Palonosetron:
Palonosetron: 75 6.8 containing 1% sodium SDS ; 500
Palonosetron: 0.01 N HCl
50 0.033 M Citric Acid Buffer, pH 4.5 900
Refer to USP
100 0.1 N HCl 1000
50 0.5% SDS in water 900
100 0.1 N HCl 900
Tier 1: 0.08M Sodium Acetate Buffer, pH
4.0; Tier 2: 0.08M Sodium Acetate Buffer,
50 900
pH 4.0 containing pepsin (750,000
units/L)
50 Phosphate Buffer, pH 6.8 1000
Refer to USP
Refer to USP
Refer to USP
100 Phosphate Buffer, pH 7.5 900
75 Phosphate Buffer, pH 7.4 900
with 1% cetrimide; Tier 2: Stage 1: 0.05
M Phosphate Buffer, pH 6.8 with
100
pancreatin (1750 USP units/L); Stage 2:
after 10 minutes of Stage 1, add 100 mL
75 3% SLS in 0.5% Sodium Chloride, pH 6.0 900
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
4 mg/mL (0.4%) Lauryldimethylamine N-
100 500
oxide (LDAO)
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
50 Water 900
Refer to FDA's Dissolution Guidance,
2018
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
Refer to USP
50 50 mM Sodium0.1 N HCl Buffer, pH
Phosphate 900
50 6.8, with 0.4% w/v Cetyl 900
Trimethylammonium Bromide (CTAB)
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
Develop a quantitative rupture test
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
50 Water (deaerated) 900
100 Water (deaerated) 900
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
75 0.1N HCl 900
75 Sodium Phosphate Buffer, pH 6.5, with 1000
0.5%Testing
Disintegration Polysorbate
in 0.1 80
N HCl as per
USP <701>
50 0.05 M Acetate Buffer, pH 4.0 500
Refer to FDA's Dissolution Guidance,
0.05 M Phosphate 2018
Buffer, pH 6.8 with
75 900
1.0% polysorbate 20
100 Water (deaerated) 500
Develop a dissolution method
Refer to USP
50 0.01 N Phosphoric Acid 900
Refer to FDA's Dissolution Guidance,
Hydroxypropyl Cellulose
2018 Solution (1 in
50 20,000). Adjust to pH 4.5 by Phosphoric 900
Buffer, pH 6.8 withAcid
1.0% Tween 80; Tier II
75 Medium: 0.05M Sodium Phosphate 900
Buffer, pH 6.8 with 1.0% Tween 80 and
Buffer, pH 6.8. Tier 2 Medium: 0.05M
75 Sodium Phosphate Buffer, pH 6.8, and 900
pancreatin with protease activity as per
0.01 N HCl with 0.2% sodium dodecyl
75 sulfate (SDS), 500
0-2 hours: 0.003% polysorbate 80, pH 1.2
100 500
2-8 hours: phosphate buffer, pH 7.2
Refer to FDA's Dissolution Guidance,
2018
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
50 Water (deaerated) 900
75 Phosphate buffer pH 6.8 with 1.0% Triton 900
X-100
Refer to FDA's Dissolution Guidance,
2018
100 1.5% (w/v) SLS (pH 3.0, adj w/ HCl) 900
50 0.05 M phosphate buffer pH 6.8 900
sodium dodecyl sulfate (SDS) (900 mL);
Tier II: 0.1 mM HCI with pepsin (as per
50 USP) (750 mL) for the first 10 minutes, 900
followed by addition of 0.1 mM HCI with
SDS (3%to
Refer w/v) (150
FDA's mL) for the
Dissolution remainder
Guidance,
2018
50 Acetate
0.5% solidBuffer with 0.15% SDS, pH 4.5
Lauryldimethylamine-oxide 500
100 (LDAO) in 0.05M Phosphate Buffer, pH 900
Refer to FDA's Dissolution
7.8 Guidance,
2018
Refer to FDA's Dissolution Guidance,
Tier 1: 0.1N HCl;
2018Tier 2: 0.1N HCl
50 containing pepsin (750,000 units per 900
1000 mL)
Refer to USP
50 0.067 M Phosphate Buffer, pH 6.8 1000
Refer to FDA's Dissolution Guidance,
0.01 N HCl with2018 1.0% sodium lauryl
75 0.75% of Polyoxyl 900
sulfate40 hydrogenated
(SLS)
75 castor oil in sodium acetate buffer 900
100 2% (22mM),
Tween 80pH in 4.5
Water 900
Refer to FDA's Dissolution Guidance,
2018
50 0.1 N HCl 900
7.5 + 2% SDS (w/w) Tier II: 0.05 M Na
phosphate buffer, pH 7.5 (700ml) + 1%
75 pancreatin. After 15 min. incubation, add 900
Acid stage: 0.1 N HCl; Buffer stage:
200 mL of phosphate buffer containg 9% 0.1 N
100 HCl:0.2M Tribasic Sodium Phosphate 1000
(3:1), pH
Refer to USP6.8
Amoxicillin/Rifabutin: 0.01 N HCl; Amoxicillin/Rifabutin:900;
100 Omeprazole: 0.1N HCl; Buffer Stage: Omeprazole: Acid Stage: 900;
Acid 0.05M Phosphate
Stage: 0.05M buffer,
Sodium pH 6.8 pH
Phosphate, Buffer Stage:900;
50 3.5 ± 0.05; Buffer Stage: 0.05 M Sodium Acid stage: 500; Buffer stage: 900
Acid stage: 0.1N HCl;pH
Phosphate, Buffer
6.8 ±stage:
0.05 0.05 M Acid stage: 1000; Buffer stage:
75
Sodium Phosphate buffer,
Acid Stage: 0.1 N HCl, Buffer Stage: pH 6.8pH 1000
100 Acid Stage: 500; Buffer stage: 900
7.0
AcidPhosphate
Stage: 0.1Buffer
N HCl;with 5 mM
Buffer SLS
Stage:
75
DiluteNa.Phosphate
HCl, pH 1.1 for Buffer,
2 hourspHand
6.5 then
add 200 mL of 0.1 N NaOH in 200 mM Acid stage: 750; Buffer stage:
75
Phosphate Buffer. Adjust pH to 6.0 using 950
2 N HCl and/or 2N NaOH
Refer to USP
Phase 1 & 2: 100 rpm; Phase Phase 1: 0.1N HCl (degas); Phase 2: pH Phase 1: 500; Phase 2: 900; Phase
3: 50 rpm 6.0 Buffer (degas); Phase 3: pH 7.2 Buffer 3: 900
Acid Stage: 0.1 N HCl; Buffer Stage:
100
Phosphate buffer, pH 6.8
Acid stage: 0.1N HCl ; Buffer stage: pH 6.8
50 Acid stage: 900; Buffer stage: 900
buffer
Refer to USP
Acid Stage:0.1 N HCl; Buffer Stage: 0.05
Acid Stage: 75 rpm; Buffer M Phosphate Buffer, pH 6.8 (After Acid Acid Stage: 750; Buffer
Stage: 60 rpm Stage, add 250 mL of 0.2 mol/L trisodium Stage:1000
phosphate solution).
Refer to USP
Refer to USP
Refer to USP
75 Acetate Buffer, pH 4.5 with 2.2% Tween 900
20
Dilute HCl, pH 1.1 for first 2 hrs, then add
0-2 hrs: 750 mL. After 2 hrs: 950
50 200 mL of 200 mM Phosphate Buffer and
adjust to pH 6.0 for the remainder mL

Media 1: pH 1.1±0.1, Dilute HCl 2 hours;


Media 2: pH 6.0±0.1, Phosphate Buffer Media 1: 750 mL; Media 2: 950
50
3rd hour, Media 3: pH 7.5±0.1, mL; Media 3: 1000 mL
Phosphate Buffer for the remainder
100 0.1 N HCl 900
Simulated Intestinal Fluid without
50 500
enzyme
First 2 hours: 0.01 N HCl, Hours 2-10:
100 Acid: 500, Buffer: 500
Phosphate Buffer, pH 6.8
100 0.1 N HCl 500
Refer to USP
Refer to USP
Refer to USP
Refer to USP
100 pH 1.2 NaCl/HCl buffer 900
50 Phosphate Buffer, pH 6.8 900
buffer pH 6.5 Comparative dissolution
50 data should also be provided in 900 ml 900
pH 0.1 HCl, pH 4.5 buffer, and water
100 0.05 M Phosphate Buffer, pH 6.8 500
Refer to USP
Refer to USP
75 Water (deaerated) 1000
100 Acid Stage: 0.1N HCl; Buffer stage: Acid stage: 700; Buffer stage:
Sodium Phosphate Buffer, pH 7.4 1000
Acid Stage: 0.1NRefer
HCl to USP
100 Buffer stage: Acid stage: 750 mL; Buffer
stage: 1000 mL
50 PhosphateWater
Buffer, pH 6.8 500
0-2 hrs:0.01 N HCl. 2-10 hrs: Phosphate
75 0-2 hrs: 500. 2-10 hrs:500
Buffer, pH 6.8.
Refer to USP
50 0.1 N HCl 1000
50 1 hour - SGF w/o Enzymes; after 1 hour - 900
SIF w/o Enzymes
Refer to USP
Refer to USP
Refer to USP 900
100 Phosphate buffer (pH 6.8) 900
100 50 mM Tris buffer, pH 7.2 900
50 0.05 M Phosphate Buffer, pH 7.5 750
100 Water (Deaerated ) 900
0.1 N HCl, pH 1.1 for 2 hrs and then add
200 mL of 0.1 N NaOH in 200 mM 0-2 hrs: 750 ml, After 2 hrs: 950
50
Phosphate Buffer. Adjust pH to 7.5 using ml.
2 N HCl and/or 2N NaOH
100 Water 900
Refer to USP
50 pH 6.8 Phosphate
0.05M Potassium PhosphateBuffer
Buffer (pH 900
100 7.4) with
0.5% SDS in 5 mM Sodiumsodium
trypsin (.001%w/v) and 900
75 azide (.025%
Dihydrogenphosphate w/v)
Monohydrate, 500
First 4 hours: Dilute Acid, pH 1.1. AfterpH
4
75 6.8
hours: Phosphate Buffer, pH 7.5 with First 4 h: 900. After 4 h: 900
0.1% sodium lauryl sulfate (SLS).
100 0.1 N HCl 900
Refer to USP
100 AcidpH 1.2 NaCl/HCl
Stage:(First Buffer0.01
2 hours) (degas)
N HCl; 900
100 Buffer Stage (2-10 hours): Phosphate Acid: 500 mL; Buffer: 500 mL
Acid Stage:(0-6 hours)
Buffer, pHSimulated
6.0 Gastric
Fluid [SGF, pH 1.2] without enzyme;
75
Buffer Stage (after six hours in acid
stage): Phosphate Buffer, pH 7.4
100 0.1 N HCl 900
50 Phosphate Buffer, pH 6.8 900

50 Acid stage: 0.1 N HCl; Buffer stage: 0.05 Acid stage: 500; Buffer stage: 500
Phosphate Buffer, pH 7.5
Develop a dissolution method
22 mM Sodium Acetate buffer, pH 4.5
100 900
with 0.03% Tween 20
100 Water (deionized and degassed) 750
Refer to USP
0.1 N HCl containing 4 mg of N,N-
75 1000
dimethydodecylamine-N-oxide per mL
75 0.025 M SLS in water 1000
100 0.01 M HCl (degas) 500
50 25 mM pH 6.8 phosphate buffer
with 2% (w/v) sodium dodecyl sulfate 900
(SDS) (900 mL) Tier II: Dissolution
Medium: 0.1 N HCI with pepsin (as per
50 900
USP) (450 mL) for the first 25 minutes,
followed by addition of 0.1 N HCI with
Ether
SDS (4%with
w/v)10 mMmL)
(450 Sodium Phosphate
for the remainder
50 monobasic (pH 6.8); Tier II: same as 900
above with NMT 1750 USP units/L of
50 0.1 N HCl/1% HCO-40 (Polyoxyl 40 900
Tier I: 0.1N HCl with 0.1%
hydrogenated Tween
castor oil) 20. Tier
75 II: 0.1N HCl with 0.1% Tween 20 with 900
150 addition of pepsin
Phosphate (as pH
Buffer, per7.2
USP). 900
150 50mM Phosphate Buffer, pH 7.2 900
50 Water (deaerated) 900
50 Water (deaerated)
pH 1.2, Simulated Gastric Fluid without 1000
100 pepsin, containing 4 % Triton X-100 900
75 0.01 N HCl with 0.5% Triton X-100
[polyoxyethylene[10]octylphenyl ether] 900
(degassed) 500 mL for 50 mg capsule; 900 mL
100 Phosphate Buffer, pH 6.8
for 250 mg capsule
100 0.1N HCl (degassed) 900
Refer to USP
Diluted McIlvaine Buffer [12.5 mM
disodium hydrogen phosphate solution
75 900
+6.25 mM citric acid solution ] + 0.5 %
Sodium Lauryl sulfate (SLS)
50 0.1 N HCl 900
Refer to FDA's Dissolution Guidance,
2018
100 1% Polysorbate 80 in Water 1000
USP IV (Flow-Through Cell), and, if
applicable, Apparatus II (Paddle) or any
other appropriate pharmacopoeial
apparatus, for comparative evaluation by
50 0.1 N HCl 900
Stage 1: 850 mL of 0.1 N HCl solution
Tier 1: 900; Tier 2: Stage 1: 850
75 with pepsin [250’000 units/L]. Stage 2:
mL, Stage 2: 900 mL
After 10 minutes add 50 mL of 18% SDS
50 Water (deaerated) 900
Deionized Water with 2% Sodium Lauryl
75 500
Sulfate (SLS)
100 0.1 N HCl 500
Refer to FDA's Dissolution Guidance,
2018
Acid stage: 0.1 N HCl; Buffer stage: pH 6.8
100 Acid stage: 500; Buffer stage: 500
Phosphate Buffer Acid stage: 500 mL [for 23.75/95
Acid stage: Simulated Gastric Fluid [SGF] mg strength], 900 mL [other
75 without enzyme; Buffer stage: pH 7.0, 50 strengths]; Buffer stage:500 mL
mM Phosphate Buffer [for 23.75/95 mg strength], 900
Refer to USP for monographs of mL [other strengths]
Amoxicillin Capsules, Clarithromycin
Tablets and Lansoprazole Delayed-
Refer toRelease
USP forCapsules
monographs of
Amoxicillin Capsules, Clarithromycin
Tablets and Omeprazole Delayed-Release
Capsules
50 Water 900
Refer to USP
Refer to USP
900 (modified from the standard
10 dpm (dip rate per minute) 0.25 N HCl apparatus 3 vessel to achieve sink
condition)
Phosphate Buffer, pH 7.4 or or any other
60 cycles (chews) per minute 20
appropriate buffer and conditions
Buffer Stage: 0.05 M Tribasic Sodium
Phosphate (Add 250 mL of 0.2 mM Acid stage: 750; Buffer stage:
100 Tribasic Sodium Phosphate after 1000
completion of acid stage); pH 6.8
100 0.1 N HCl 900
50 Simulated Gastric Fluid (SGF) at 37ºC ± 495
0.5ºC

75 0.1 N HCl 900

0.05M NaH2PO4.H2O Phosphate Buffer,


100 60
pH 4.5

100 25-mM Phosphate Buffer, pH 6.4 60

100 25-mM Phosphate Buffer, pH 6.4 100

50 0.1 N HCl 900

75 20mM BIS-TRIS HCl Buffer, pH 6.4 500


Acetate Buffer, pH 4.0 (12.5mM Sodium
acetate trihydrate and 60mM glacial
100 900
acetic acid. Adjust the pH with glacial
acetic acid or ammonium hydroxide).
0.1% Hydroxypropyl-beta-cyclodextrin at
50 900
32º C

50 0. 9 % NaCl at 32º C 500

50 0.9% Sodium Chloride at 32°C 600


Develop a method to characterize in vitro
release
Develop a method to characterize in vitro
release
0.025 mg/24 hr and 0.0375 mg/24
hr: 500 mL; 0.05 mg/24 hr, 0.075
50 Water at 32 ± 0.5°C
mg/24 hr and 0.1 mg/24 hr: 900
mL
50 Water at 32 ± 0.5°C 900

0.0375 mg/24 hr: 500 mL; 0.05


50 Water at 32 ± 0.5°C mg/24 hr, 0.075 mg/24 hr and 0.1
mg/24 hr: 900 mL

0.1 M sodium chloride containing 2.5%


(v/v) of Tween 40 at 32 ± 0.5°C. Delivery
50 900
surface faces upwards towards the
media.
80 microL /L phosphoric acid (85%) at 32
50 1000
± 0.5°C
Refer to USP

100 Deionized Water at 32º C 900

0.25% Sodium Dodecyl Sulfate (SDS)


50 Solution 900

Flow @ 3 mL/min 1% SLS in pH 6.8 Phosphate Buffer use Open Mode

75 50 mL of methanol to 950 mL of water 950

25 Water (deaerated) 900


25 Water 900
40 Water with 2% Tween 80 900
100 Acid stage: 0.1 N HCl; Buffer stage: Acid stage: 300; Buffer stage:
Sodium Phosphate Buffer, pH 6.8 1000
50 Water (degassed) 900
50 Water (with
Phosphate 1.2%
Buffer, pH Tween 80)
6.8 containing 900
25 0.16% w/v cetyl trimethylammonium 900
bromide (CTAB)
Develop a dissolution method(1 in
Hydroxypropyl Cellulose Solution
50 20,000). Adjust to pH 4.5 by Phosphoric
Pre-exposed to 300 mL of 0.1M HCl for 2
Acid
hrs and then 700 mL of 0.086 M Acid stage: 300; Buffer stage:
100
Na2HPO4 is added to the medium to give 1000
Acid stage: 0.01mL
1000 N with
HCl; Buffer
pH 6.8stage: pH Acid stage: 750 mL; Buffer stage:
75 6.8 Phosphate buffer with 1.3% Tween
1000 mL
100 Phosphate 80;
Buffer, pH 6.8 1000
50 0.5% Benzalkonium Chloride in water 900
Develop a method to characterize in vitro
release
50 0.05 M Phosphate Buffer, pH 6.8 500
Develop a method to characterize in vitro
release
Phosphate Buffer, pH 6.8 with 0.5%
75 900
Tween 20
50 0.5% w/v SDS in Water 900
50 Phosphate Buffer, pH 6.8 900
60 50 mM Phosphate Buffer, pH 6.8 900
Acid Stage: 0.1 N HCl; Buffer Stage 2: pH
100 1000
7.5 Phosphate Buffer
75 rpm (for 75 mg strength);
Acid Stage: 0.1 N HCl; Buffer Stage: 0.2M Acid Stage: 1000; Buffer
150 rpm (for 300 mg
strength) Sodium Phosphate buffer, pH 6.8 Stage:1000

50 0.1 N HCl 900


Develop a dissolution method
Stage 1: USP Phosphate Buffer (0.036
100 mol), pH 6.8 (0-4 hours); Stage 2: Stage 1: 500; Stage 2: 1000
Phosphate Buffer pH 6.8 (0.108 mol),
(after 4 hours)
50 Water 900

Each implant should be incubated in 50


Swirl orbit of 50 mm at 205 mL of phosphate buffered saline, pH 7.4,
at 39°C (warmed overnight before the 50
rpm for 6 seconds
implants are added), in a 120-mL
Wheaton jar.
Develop a method to characterize in vitro
releas
Phosphate Buffered Saline containing
30 cycles per min 0.05 g/L sodium dodecyl sulfate at 45 ± 30
0.5°C
Develop a method to characterize in vitro
release
IV (Flow-Through Cell), and, if applicable,
Apparatus II (Paddle) or any other
appropriate method, for comparative
Develop a method to characterize in vitro
Develop a method release.
to characterize in vitro
release
IV (Flow-Through Cell), and, if applicable,
Apparatus II (Paddle) or any other
appropriate method, for comparative
IV (Flow-Through Cell), and, if applicable,
Apparatus II (Paddle) or any other
appropriate method,
Develop a method for comparative
to characterize in vitro
release, starting at pH 6.00 ± 0.05 and at
47ºC ± 0.5ºC. Replicate for 12 dosage
Develop a methodvials.
to characterize in vitro
release
Develop a dissolution method
release method using USP IV (Flow-
Flow @ 8 mL/min Through Cell), and, if applicable,
Apparatus II (Paddle) or any other
Water-Methanol (95:5);for
appropriate method, Reconstitute
comparativevial
200 in 2 mL Water for Injection, add to 500 500
mL medium
50 mM Acetate Buffer,atpH
37°C
4.5 @37°C ±
Flow @ 6 mL/min 0.5 [use glass beads; sample volume: 100 480
μl]

Test 1: 0.5 % SDS in water ; Test 2: 0.35 %


Test 1: 17 mL/min; Test 2: 50 Test 1:use Open Mode: Test 2:
SDS in water (provide data with both
rpm 900 mL
tests)
Develop a method to characterize in vitro
release
0.55 % SDS
7.4 (final osmolality should be 270 ± 20
mOsm), or any other appropriate
medium, at 37°C. Develop an in vitro
release method using USP IV (Flow-
Through Cell), and, if applicable,
Apparatus II (Paddle) or any other
IV (Flow-Through Cell), and, if applicable,
Apparatus II (Paddle) or any other
appropriate method, for comparative
0.3% SDS in 10 mM phosphate buffer, pH
75 1000
7.2 + 0.02% sodium azide @35°C
0.489% (w/v) Polysorbate 20 in 0.001 N
50 900
0.489% (w/v)HCl @25.0 °C.20 in 0.001 N
Polysorbate
50 900
HCl @25.0
Develop a method °C.
to characterize in vitro
release
Refer to USP
100 Phosphate Buffer, pH 7.4 900

20 dpm Phosphate buffer pH 7.4 250

175 0.1 M Phosphate Buffer, pH 4.5 500


Develop a method to characterize in vitro
Develop a method release
to characterize in vitro
release
Develop a method to characterize in vitro
Develop a method release
to characterize in vitro
release
Develop a method to characterize in vitro
Develop a method release
to characterize in vitro
release
Develop a method to characterize in vitro
Develop a method release
to characterize in vitro
release
Develop an in vitro release method
Develop a dissolution method
Develop a dissolution method
50 Phosphate buffer, pH 6.0 900
100 0.05 M Acetate Buffer with 0.025% Brij35 900
(polyoxyethylene lauryl ether), pH 4.5
75 0.1 N HCl (degassed) 900
75 0.05% Polysorbate 20 in 0.05M 900
Phosphate Buffer, pH 6.8
Develop a dissolution method
25 10 mM HCl 900
0.54% Sodium Lauryl Sulfate (SLS) in
25 and 50 1000
Water Sulfate (SLS) in
0.54% Sodium Lauryl
25 and 50 1000
Water
25 0.01 N HCl 900
Refer to USP
50 0.1NatHCl
Phosphate buffer pH 7.5 with 6% 900
100 hexadecyltrimethyl ammonium bromide, 900
25, 50 and 75 bath temperature at 25ºC
0.1 % and 0.2% SLS in water 900
25 0.1 N HCl 900
25 0.3% SLS 900
30 1% SLS in 0.1N HCl 900
0.1M HCL for 2 hrs and then 700 mL of
300 ml for the acid stage; 1000 ml
100 0.086 M Na2HPO4 is added to the
for the buffer stage
medium containing the capsule to give
Tablets are pre-exposed to 750 ml of
0.1M HCL for 2 hrs and then 250 ml of Acid stage: 750; Buffer stage:
100
0.2M Na3PO4 is added to the medium to 1000
givefor
0.1M HCL 1000 mland
2 hrs withthen
pH 6.8
400 ml of
100 0.235M Na2HP04 is added to the Acid stage: 500; Buffer stage: 900
medium. Adjust if necessary with 2 N HCI
Develop a method to characterize in vitro
Develop a method release
to characterize in vitro
release
Develop a method to characterize in vitro
release
Develop a dissolution
1.0% polysorbate 80 in 25 mM method
Potassium
75 Phosphate Buffer, with 0.005 mg/mL 900
25 mM Potassium
Butylated Phosphate
Hydroxytoluene Buffer,
(BHT), pH
pH 5.5
75 900
5.5
100 0.1 N HCl 900
75 Simulated Intestinal Fluid 900
100 0.2% polysorbate
0.05M 80 in 0.01
phosphate buffer M HCl
(TriSodium 900
75 Phosphate Dodecahydrate in 0.1 N HCl 400
50 and pH0.1
adjusted
N HCl to 6.8) 900
75 0.4 M Phosphate Buffer, pH 4.5 900
0.25 mM Sodium Phosphate Buffer, pH
50 7.4 900
50 Phosphate Buffer, pH 7.2 900
Refer to USP

100 0.1 N HCl at 38° C 900

Develop a method to characterize in vitro


0.025 M Sodiumrelease
Phosphate Buffer with
50 0.03% Sodium Dodecyl Sulfate (SDS), pH 900
50 Phosphate7.4
buffer, pH 5 900
For 500 mg strength: 0.2 M Phosphate
75 (for 500 mg) & 125 (for buffer, pH 7.5 at 37 deg. C For 1000 mg 900
1000 mg) strength: 0.2 M Phosphate buffer, pH 7.5
at 40 deg. C
100 0.45% SLS in water 900

100 0.12 N HCl with 1% SLS 900

50 0.1 N HCl 900


75 Water (deaerated) 900
50 Water (deaerated) 900
25 Water 900
50 0.05 M Phosphate buffer, pH 6.8 900
50 0.05 M Phosphate buffer, pH 7.2 900
50 Glycine Buffer (0.04 M) pH 3.0 900
25 Water (deaerated) 900
50 0.05 M Phosphate Buffer, pH 7.0 1000
25 Water 900
Develop a dissolution method
50 0.05 M Phosphate Buffer, pH 6.8 900
50 Acetate Buffer (pH 4.0) 900
25 0.01 N HCl 900
75 pH 4.0 Acetate Buffer 900
50 mM potassium phosphate in water,
50 750
pH 6.8 with
Monobasic 0.2%Phosphate,
Sodium polysorbatepH806.8
75 900
Buffer with 1% SLS Buffer w/ 1% SLS
25 and 50 0.1 M Phosphate buffer, pH 4.5 900
50 Water (deaerated) 900
50 0.001 N HCl 900
50 Water (deaerated) 900
50 Water (deaerated) 500
Develop a dissolution method
Refer to USP
50 0.05 M Phosphate Buffer, pH 7.2 900
50 0.05 M Phosphate Buffer, pH 6.8 900
25 Phosphate buffer at pH 7.5 900
40 0.1 N HCl 900
Develop a dissolution method
25 0.1 N HCl 900
50 pH 1.2 HCl Buffer (degassed) 1000
50 Phosphate Buffer, pH 7.2 900
75 1% SDS in water 900
100 SGF without enzyme 900
900 [890 mL 0.1 N HCl + 10 mL
50 0.1 N HCl
perampanel suspension]
Refer to USP
900 [890 mL of medium + 10 mL
35 Phosphate Buffer pH 4.5
2.0% SDS (sodium dodecyl sulfate) in of suspension]
50 900
water
50 McIlvaine Buffer, pH 5.0 500
50 Phosphate Buffer, pH 7.0, with 0.14% 900
sodium dodecyl sulfate (SDS)
50 0.1 N HCl 900
75 0.1N HCl/0.067 M KCl, pH 1.0 900
50 1 mL of 0.2 N HCl in water 900
50 0.1 N HCl 900
25 0.05 M Sodium Acetate Buffer, pH 4.5 500
50 Phosphate Buffer, pH 6.0 900
Acid Stage: 0.1 N HCl; Buffer Stage: pH
6.8 Phosphate Buffer [500 mL 0.1 N HCl Acid Stage: 500 mL; Buffer Stage:
50
for 1 hour, followed by addition of 400 900 mL
mL of 0.2M NaH2P04 to pH 6.8]
50 0.1 N HCl 500
900 [ 895 mL 0.4 M Buffer +5 mL
50 0.4 M Phosphate Buffer
Suspension]
Develop a dissolution method
Develop a dissolution method
Develop a method to characterize in vitro
release
50 Phosphate Buffer, pH 7.2 900
Refer to FDA's Dissolution Guidance,
0.01 M Phosphate 2018Buffer with 0.5%
85 900
sodium dodecyl sulfate (SDS), pH 6.8
75 0.1 N HCl 900
Acid Stage: 900 mL; Buffer Stage:
75 0.1 N HCl
1000 mL
75 0.01 N HCl 900
50 0.25% SLS in 56.5 mM phosphate buffer, 900
pH 4.5
75 Water (deaerated) 900
Refer to FDA's Dissolution Guidance,
2018
Refer to USP
50 Water (deaerated) 900
Refer to USP
50 Water 900
Refer to USP (provide individual unit
data).
50 50 mM Phosphate Buffer, pH 7.2 900
Refer to USP
100 Water (deaerated) 900
Refer to USP
Refer to USP
50 0.1 N HCl 900
Refer to USP
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
For Alendronate: 50; For For Alendronate: Deaerated Water; For For Alendronate: 900; For
Cholecalciferol: 75 Cholecalciferol: 0.3% SDS in USP Water Cholecalciferol: 500
Refer to FDA's Dissolution Guidance,
2018
100 0.01 N HCl, pH 2.0 500

100 0.01 N HCl 900

100 0.1 N HCl 900


Refer to USP
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
50 0.01 N HCl 900
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
75 0.05 M Acetate Buffer, pH 5.0 900
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
Refer to USP
Refer to USP
100 1% SLS in water 1000
50 Acetate Buffer, pH 4.0, with 1% Tween 80 900
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
75 Phosphate Buffer, pH 6.8 900
50 Phosphate Buffer, pH 6.8 900
Telmisartan: Phosphate Buffer, pH 7.5;
75 Telmisartan: 900; Amlodipine: 500
Amlodipine:
Refer 0.01N HCl,Guidance,
to FDA's Dissolution pH 2
2018

100 Deionized Water 500

Refer to FDA's Dissolution Guidance,


0.25% sodium lauryl2018sulfate (SLS) in 0.05
75 900
M Sodium Phosphate
0.05 M Sodium Phosphate Buffer, pH with
Buffer 4.5
75 900
0.15% SLS in0.05%
25 mMSLS,Sodium
pH 6.8 Phosphate
60 900
Buffer, pH 6.8
50 0.1 N HCl 900
Refer to USP
75 Water (deaerated) 900
75 Acetate Buffer, pH 4.5 900
100 Water (deaerated) 900
50 Water (deaerated) 900
Refer to USP
75 0.05 M Citrate Buffer (pH 2.8) 1000
75 0.05 M Phosphate buffer, pH 6.8 900

Phosphate buffer, pH 6.8 with 0.2% w/v


75 900
Tween 80
40% isopropanol buffered to pH 8.0 with
50 900
potassium dihydrogen phosphate
40% isopropranol buffered to pH 8.0 with
50 900
potassium dihydrogen phosphate
0.05 M Sodium Acetate Buffer, pH 5.0
75 containing 0.5% w/v cetyl 900
trimethylammonium bromide (CTAB)
Refer to USP
50 Phosphate Buffer, pH 7.8 (deaerated) 900
Phosphate Buffer, pH 6.8 containing 1.0%
50 900
Tween 80,
Phosphate Buffer,to
Refer pHUSP
6.8 containing
50 0.16% w/v cetyl trimethylammonium 900
100 bromide
Water (CTAB)
(degassed) 1000
50 0.05 M Phosphate
Bempedoic Acid: 0.05buffer, pH 6.6
M Phosphate 900
50 buffer, pH 6.6; Ezetimibe: 0.05M Sodium 900
50 Acetate Buffer
WaterpH 4.5 with 0.45% SLS
(deaerated) 500
100 0.1 N HCl 500
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
100 0.1 N HCl 900
Refer to FDA's Dissolution Guidance,
2018
Refer to USP
50 1% SLS in water 1000
Refer to FDA's Dissolution Guidance,
2018
75 0.1 N HCl 900
50 1% SLS in water 900
50 0.05 M Acetate buffer, pH 4.3 900
50 mM Potassium Phosphate Buffer, pH
70 900
7.2
Refer to USP
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
50 Water (Deaerated) 500
Refer to FDA's Dissolution Guidance,
0.01N HCl with 0.2%
2018
60 cetyltrimethylammonium bromide 1000
Refer to FDA's Dissolution
(CTAB) Guidance,
2018
Refer to USP
0.75 % sodium lauryl sulfate (SLS) in
75 600
Canagliflozinwater
(50 mg): 0.025 %
Canagliflozin (50 mg): 900;
Canagliflozin: 75; Metformin: Polysorbate 20; Canagliflozin (150
Canagliflozin (150 mg): 900 ;
50 mg):0.075 % Polysorbate 20; Metformin:
Metformin: 1000
Phosphate
0.35% buffer,
Polysorbate 20 pH 6.8 M
in 0.05
50 900
Phosphate Buffer, pH 6.5 M
0.70% Polysorbate 20 in 0.05
50 900
Phosphate Buffer, pH 6.5
0.35% Polysorbate 20 in phosphate
50 900
buffer pH 6.5
0.70% Polysorbate 20 in phosphate
50 900
buffer pH 6.5
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
75 0.01N HCl (degassed) 900
Refer to FDA's Dissolution Guidance,
2018
For both Carbidopa and Levodopa: 0.1 N
Carbidopa and Levodopa: 50; Carbidopa and Levodopa: 750 ml.
HCl, For Entacapone: Phosphate buffer
Entacapone: 125 Entacapone: 900 ml
pH 5.5
Refer to FDA's Dissolution Guidance,
2018
Refer to USP
Refer to USP
Refer to USP
50 SGF without enzyme 900
75 50 mM phosphate buffer, pH 6.8 900
Refer to USP
75 Simulated Gastric Fluid without enzyme 900
Refer to USP
Refer to USP
Refer to USP
Refer to USP
75 0.01N HCl
75 0.01 N HCl (degassed) 900
75 0.1 N HCl 900
Refer to FDA's Dissolution Guidance,
50 mM Potassium2018 Phosphate Buffer, pH
50 900
6.5 (degassed)
50 0.05 M Phosphate Buffer, pH 6.5 900
Refer to USP
Refer to USP
75 0.3% SLS in water 900
75 0.05 N HCl 900
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
50 Phosphate Buffer, pH 6.8  (deaerated) 900
Refer to USP
75 0.1 N HCl (degassed) 900
Refer to FDA's Dissolution Guidance,
2018
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
Refer to USP
75 50 mM Sodium Acetate Buffer, pH 4.5 900
Cobi: 0.05 M Citrate Phosphate Buffer,
Cobi: 75; Drv:75 pH 4.2; Drv: 0.05 M Sodium Phosphate Cobi: 900 mL; Drv: 900 mL
Buffer, pH 3.0, 2% Tween 20
0.05 M sodium citrate buffer pH 5.5
100 1000
containing 2.0% w/v polysorbate 80
Refer to FDA's Dissolution Guidance,
2018
Refer to USP
Disintegration Testing as per USP
<701> in various media such as deionized
water, simulated gastric fluid and
simulated intestinal fluid.
Refer to USP
100 Water (deaerated) 900
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
1% sodium lauryl sulfate (SLS) in 0.01N
75 1000
2% Tween-20 in HCl0.05 M Sodium
75 900
Phosphate Buffer, pH 3.0
Drv: 0.05 M Sodium Phosphate Buffer,
75 pH 3.0, 2% Tween 20; For Cobi, Emt and 900
Taf: Citrate Phosphate Buffer, pH 4.2
60 pH 4.0 Acetate buffer containing 1% 1000
Refer to FDA'sTriton X-100 Guidance,
Dissolution
100 Acidic Stage: 0.1 N2018
HCl, Buffer Stage: 0.05
M Phosphate
0.05 M Phosphate buffer, pHpH
Buffer, 6.8.7.4
60 900
(degassed)
0.05 M Phosphate Buffer, pH 6.0
50 containing 0.6% w/v SDS 900
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
Refer to USP

75 pH 3.0 Acid Phthalate Buffer 500


Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
100 Water 500
Refer to USP
50 SIF without enzyme 900
Refer to USP
50 0.4% SLS in water 900
Refer to USP
Refer to USP
50 50 mM Phosphate Buffer, pH 6.5 900
Refer to USP
100 2% SDS 900
Refer to USP
75 1.0 % Tween 20 in 0.01 M HCl, pH 2.0 900
50 0.01M
0.01M pHpH 6.8
6.8 phosphate
phosphate buffer
buffer 900
50 containing 0.15% w/v sodium dodecyl
0.01M pH 6.8 phosphate buffer 900
50 sulfate (SDS)
containing 0.25% w/v sodium dodecyl 900
50 sulfate
0.01 N(SDS)
HCl 900
Simulated Gastric Fluid w/o enzyme (pH
50 900
Refer to FDA's 1.1-1.3)
Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
75 pH 4.5 Phosphate buffer 1000
50 Water 900
50 2% SLS in water 1000

100 2% SLS in water 1000

75 2% SLS in Water 1000


50 0.05 M Sodium Phosphate, pH 6.8 900
100 0.1 N HCl 900
0.5% Polysorbate 80 in Phosphate Buffer,
50 900
pH 6.8
700 mL for 85 mg tablets; 1000
2.0% w/v Polysorbate 80 in 0.01 N HCl
75 mL for 150 mg tablets 1000 mL for
(pH 2.0) at 37 ºC
150 mg tablets
Refer to FDA's Dissolution Guidance,
2018
50 pH 6.8 Phosphate Buffer 900
50 0.01 N HCl 900
Refer to USP
50 Phosphate Buffer, pH 5.5 900
Refer to FDA's Dissolution Guidance,
2018
50 Phosphate Buffer, pH 7.5 900
Refer to FDA's Dissolution Guidance,
2018
75 0.2 M Phosphate Buffer, pH 7.5 1000
75 0.2 M Phosphate Buffer, pH 7.5 1000
75 0.02% Tween 80 in 0.01 N HCl 1000
Refer to USP
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
100 Acetate Buffer, pH 4.5 1000
50 Water (deaerated) 900
50 Water 900
50 0.3% SLS in water 500
50 Water Buffer (pH 4.5);
EC: 0.02 M Na Acetate 900
50 MPA: 0.54% Sodium Lauryl Sulfate [SLS] 900
50 inWater
water 900
Refer to FDA's Dissolution Guidance,
2018
Refer to USP
0.25% Sodium Lauryl Sulfate (SLS) in
75 600
Water
Refer to USP
Refer to USP
Refer to USP
Refer to USP
Refer to USP
75 0.05% Tween 20 in water 600
75 0.05% Tween 20 in water 600
75 Water with 5 ppm of Tween 80 500
75 0.1 N HCl 900
Refer to USP
Refer to USP
50 Water with 0.4% sodium dodecylsulfate 500
100 0.5%(w/v) SLS Solution 900
0.45% SLS in 0.05 M Acetate Buffer, pH
50 500
4.5
0.01 M Sodium Phosphate, pH 7.0/0.5%
50 900
SDS
Refer to FDA's Dissolution Guidance,
2018
Refer to USP
Refer to USP
75 Phosphate buffer, pH 6.8 900
EDTA media ( 2.0 grams of EDTA Na2
100 900
2H2O to 1000 mL of purified water)
50 0.001 N HCl 900
Refer to FDA's Dissolution Guidance,
Acetate Buffer,2018
pH 4.5 (for 10 mg
75 strength) and Acetate Buffer, pH 4.5 with 900
100 0.1% polysorbate 0.120N(for
HCl20 mg strength) 900
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
50 Water 900
Refer to USP
Refer to USP
Refer to FDA's Dissolution Guidance,
250 mM Sodium2018 Acetate/Acetic acid
75 900
buffer pH 3.5
50 Water (deaerated) 900
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
Refer to USP
50 Tween 80 (5% v/v) in water 1000
Refer to USP
50 0.01 N HCl 900
50 0.1 N HCl 900
75 Phosphate Buffer, pH 7.8 900
For Pioglitazone: pH 2.0, HCl Buffer.
For Glimepiride: pH 6.8,
75 900
Sodium Phosphate Buffer with 0.2%
0.01 M sodium
HCl withdodecyl sulfateDodecyl
0.5% Sodium
75 900
Sulfate
Refer to USP
Refer to USP
50 0.05 M Phosphate Buffer, pH 7.5 900
75 0.05 M Borate Buffer, pH 9.5 500
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
Refer to USP
Refer to USP
Refer to FDA's Dissolution Guidance,
500
2018
Refer to USP
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
50 0.1 N HCl 1000
50 0.1 N HCl 900
100 Water (deaerated) 900
50 0.1 N HCl 900
50 0.05 M Phosphate Buffer, pH 6.8 900
100 Water (deaerated) 900
Refer to USP
Refer to USP
50 Phosphate Buffer, pH 7.2 900
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
50 0.1N HCl 900
3.0% w/v Polysorbate 20 in 50 mM
75 900
6.0%Phosphate Buffer,20
w/v Polysorbate pHin6.8
50 mM
75 900
Phosphate Buffer, pH 6.8
Refer to USP
100 Phosphate buffer, pH 7.2 500
75 0.01 N HCl 750
50 0.1 N HCl 500
Refer to FDA's Dissolution Guidance,
2018
Refer to USP
Refer to USP
50 0.1 N HCl 900
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
50 Water (deaerated) 900
0.5% sodium lauryl sulfate (SLS) in Water
50 900
Refer to FDA's (degas)
Dissolution Guidance,
50 mM Sodium Phosphate
2018 Buffer with
65 0.7% Sodium Dodecyl Sulfate (SDS), pH 900
Lumacaftor: 0.5% (w/v)
6.8 CTAB in 50 mM
Sodium Acetate Trihydrate buffer (pH
Lumacaftor:65; Ivacaftor: 65 Lumacaftor: 900; Ivacaftor: 900
4.5); Ivacaftor: 0.4% (w/v) SLS in 50 mM
Sodium
0.5% SDS inPhosphate buffer (pHSodium
0.01 M Monobasic 6.8)
50 900
Phosphate, pH 7.0
50 mM Phosphate Buffer pH, 6.8 with
50 900
0.6% sodium dodecyl sulfate (SDS),
100 Simulated gastric fluid w/o pepsin 800
50 SIF Buffer without enzyme, pH 7.4 900
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
75 0.1 N HCl 900

75 Water 900
75 0.1 N HCl 900
Refer to USP
50 0.01 N HCl 900
55 2% Polysorbate 80 in 0.1 N HCl 900
Refer to FDA's Dissolution Guidance,
1.5% Polysorbate 80 in 10 mM Potassium
2018
75 Phosphate Buffer with 0.0075 mg/mL 900
50 Butylated Hydroxytoluene
0.1 N HCl (BHT), pH 6.0 1000
100 Water (deaerated) 1000
Water (deaerated) + 0.6%
100 1000
Polyoxyethylene Lauryl Ether
50 0.1 N HCl 900
25 mM Na Acetate Buffer, pH 4.5 with
75 900
0.6%Dissolution
Refer to FDA's Tween-80 Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
Refer to USP 900
Refer to FDA's Dissolution Guidance,
2018
75 0.1 N HCl with 0.1% SLS 1000
Refer to FDA's Dissolution Guidance,
2018
Refer to USP
50 0.1 N HCl 900
Refer to FDA's Dissolution Guidance,
2018
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
50 0.01 N HCl 900
Refer to FDA's Dissolution Guidance,
2018
75 0.1N HCl 500
Refer to USP
McIlvaine buffer, pH 3.8 [(0.025 M Citric
acid Solution + 0.05M Na2HPO4 solution
50 900
(3:2)] Measure the pH and adjust to 3.8,
if necessary.
Phosphate Degas
Buffer, before
pH 6.8 with use.
0.1% of
75 900
Cetrimonium bromide (CTAB)
100 Water 900
Refer to FDA's Dissolution Guidance,
2018
50 0.1N HCl (deaerated) 900
Refer to FDA's Dissolution Guidance,
2018
100 0.01 N HCl 900
Refer to USP
100 SGF without enzyme 900
75 Phosphate Buffer, pH 7.5 900
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
Refer to USP
50 0.1 N HCl 900
50 0.06 N HCl 500
Refer to USP
Refer to USP
Refer to FDA's Dissolution Guidance,
2018 (0.1 M Citric acid
pH 2.5 McIlvaine buffer
50 900
adjusted to pH 2.5 with 0.2 M Na2HPO4)
75 0.025 M NaCl 900
50 Citric acid/phosphate buffer, pH 5.0 900
Refer to FDA's Dissolution Guidance,
2018
100 pH 4.5 Acetate Buffer 900
Refer to USP
Refer to USP
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
Refer to USP
50 Water 900
Refer to USP
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
75 0.01 N HCl 900
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
50 Water (deaerated) 500
Refer to USP
50 0.1 N HCl 900
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
50 0.5% SDS in water 900
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
50 0.1 N HCl 900
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
Refer to USP
Refer to USP
0.1M Sodium Phosphate buffer, pH 7.4
75 900
(deaerated)
75 0.1M Sodium Phosphate Buffer, pH 7.4 900
75 Phosphate Buffer, pH 6.8 900
Refer to FDA's Dissolution Guidance,
2018
50 0.01 N HCl with 0.5% (w/v) SLS 1000
50 0.01 N HCl 900
67 mM Phosphate Buffer pH 6.8 with
100 900
0.5% SDS
50 0.1 N HCl 900
50 0.1 N HCl 900
50 0.05 M Phosphate Buffer, pH 6.8 900
Refer to USP
Acetate buffer pH 4.5 with 1% sodium
100 dodecyl sulfate (SDS) for 30 mg strength 900
Dodecyl
and 1.5 %Sulfate
SDS for(SDS) (forstrength
120 mg 30 mg
100 900
strength) and 1.5 % SDS (for 120 mg
Develop buffer
Phosphate a dissolution method
at pH 7.5 with 6%
75 hexadecyltrimethyl ammonium bromide, 900
bath temperature at 25ºC 2 mg tablets: 500 mL; 5 mg and 10
50 Phosphate Buffer, pH 6.8
mg tablets: 900 mL
Refer to USP
Refer to USP
75 Water with 0.1% SLS 900
0.08% polysorbate 80 in 50mM sodium
75 phosphate 900
Refer to FDA'sdibasic buffer,Guidance,
Dissolution pH 6.8
2018
Refer to FDA's Dissolution Guidance,
2018
Refer to USP
M sodium phosphate buffer, pH 6.8 with
0.3% polyoxyethylene 10 lauryl ether;
75 900
Dasabuvir sodium: 0.05 M Sodium
Phosphate buffer,
Refer to FDA's pH 6.8 with
Dissolution 15 mM
Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
2% Sodium Dodecyl Sulfate (SDS) in
50 900
Water
Refer to USP
60 0.3% SDS in water 900
60 0.6% SDS in water 900
60 1% SDS in water 900
Refer to FDA's Dissolution Guidance,
2018
75 0.1 N HCl 900
50 Phosphate Buffer, pH 4.5 900
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
50 mM Sodium Acetate buffer, pH 4.5,
75 900
containing 0.75% SDS
50 0.01 N HCl 500
75 Water (deaerated) 900
Refer to USP
50 0.1 N HCl 900
Simulated gastric fluid TS with cysteine
50 500
without enzymes
50 0.1 N HCl 900
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
Simulated Gastric Fluid without enzymes,
50 900
pH 1.2
Refer to FDA's Dissolution Guidance,
2018
Develop a dissolution method
Refer to FDA's Dissolution Guidance,
2018
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
75 HCl-0.3 M KCl Buffer, pH 2.0 900
Refer to FDA's Dissolution Guidance,
2018
50 pH 2.1, KCl/HCl buffer (degassed) 900
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
Refer to USP
Refer to USP
Refer to USP
0.1 N HCl with 0.5%
75 1000
hexadecyltrimethylammonium (HDTMA)
Refer to FDA's Dissolution Guidance,
2018
Refer to USP
75 0.1 N HCl 500
Refer to FDA's Dissolution Guidance,
2018
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
Refer to USP
50 Water (deaerated) 900
Refer to FDA's Dissolution Guidance,
2018
50 0.1% Polysorbate 80 in water 1000

100 Water (Deaerated) 900


Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
Refer to USP
Refer to FDA's Dissolution Guidance,
Acetate Buffer pH2018
4.5 with 0.1% Sodium
75 900
Dodecyl Sulfate (SDS)
50 50 mM Citrate Buffer, pH 5.5 900
Refer to USP
50 Water (deaerated) 900
50 0.01N HCl (degassed) 900
50 0.8% SLS in Phosphate Buffer, pH 7.0 900
50 0.1 N HCl 900
50 Water 900
75 pH 6.8 Phosphate Buffer with 0.1% 900
10 mM Sodium
Sodium Acetate
Lauryl Buffer,
Sulfate pH 4.5,
[SLS]
75 containing 0.25% (w/v) sodium dodecyl 900
sulfate
Refer to(SDS)
USP
50 0.1 N HCl 500
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
50 0.05 M Sodium Acetate buffer, pH 4.0 900
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
0.1 N HCL with Sodium Chloride [2%
100 900
Refer (wt/vol)
to FDA'ssolution],
DissolutionpHGuidance,
1.2
2018
50 Citrate Buffer (pH 3.0) 900
10 mM Citric Acid Buffer, pH 4.5 with
75 900
50 mM Phosphate 0.5% SDS with 0.05% Brij
Buffer
70 500
35 (polyoxyethylene lauryl ether), pH 6.8
75 0.05 M Sodium Acetate Buffer, pH 4.5 900
Disintegration Testing in 0.1 N HCl as per
USP <701>
Disintegration Testing in 0.1 N HCl as per
USP <701>
100 0.01 N HCl 900
Refer to USP
Phosphate Buffer, pH 6.8 with 0.1% (m/v) 900 mL [for 2 mg strength] 500
50
Polysorbate 80 mL [for 0.25 mg strength]
120 0.4% SLS in water 500
Refer to FDA's Dissolution Guidance,
2018
10 mM Sodium phosphate buffer
100 containing 1% Tween 80 with 50 μg/mL 900
Butylated hydroxyanisole

100 Water (deionized) 900

75 500.05
mM M Phosphate
sodium Buffer,
acetate pH 6.8
buffer,pH 5.0, 900
75 with 0.5% w/v Cetyltrimethyl ammonium 900
Refer to FDA's Dissolution
bromide (CTAB) Guidance,
2018
100 0.1 N HCl 900
75 0.1 M HCl with 1% SDS 900
Refer to USP
75 0.1 N HCl/0.067 M KCl, pH 1.0 900
Refer to USP
Refer to USP
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
75 0.4% Sodium Lauryl Sulfate in Water 900
50 0.5% Sodium Lauryl Sulfate 1000
0.01M Sodium phosphate buffer, pH 6.8,
75 900
with 0.20% w/v of Polysorbate 20
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
50 0.01 N HCl 900
60 0.05 M phosphate buffer pH 6.8 900
50 Water (Deaerated) 500
50 1% SLS in Water 900
50 0.1 N HCl 900
50 0.1 N HCl 900
75 9.4 mM Citrate Buffer, pH 4 900
50 0.1 N HCl 900
50 Water (deaerated) 900
50 Citrate Buffer, pH 3.0 adjusted with HCl 500
50 0.05 M Phosphate Buffer, pH 6.8 1000
50 0.1 N HCl 900
Refer to FDA's Dissolution Guidance,
2018
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
75 0.2% w/v Polysorbate 80 in water 900
50 Water (deaerated) 900
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
50 0.1 N HCl 900
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
Refer to USP
Refer to FDA's Dissolution Guidance,
2018 Sulfate (SLS) in
0.22% Sodium Lauryl
50 900
Water
Refer to FDA's Dissolution Guidance,
2018
50 0.02 N HCl 1000
50 0.1 N HCl 900
75 0.1 N HCl 900
Refer to FDA's Dissolution Guidance,
2018 Acetate with
pH 4.5, 50 mM Sodium
60 500
0.75% Sodium Lauryl Sulfate [SLS]
50 Water (deaerated) 500
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
75 0.1N HCl with 1% Tween 20 1000
Refer to USP
Refer to FDA's Dissolution Guidance,
0.1 M Citrate Buffer,
2018pH 3.4, containing
75 0.05% Brij 35 (polyoxyethylene lauryl 900
50 ether)
0.1 N HCl 900
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
pH 1.2 Buffer [0.05 M KCl in water, adjust
50 1000
Referthe pH with
to FDA's HCl or NaOH]
Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
1% hexadecyltrimethylammonium
2018
75 bromide (HTAB) in 0.05 M Phosphate 900
Refer to FDA's Dissolution
Buffer, pH 6.8 Guidance,
2018
Refer to USP
75 0.01 N HCl, pH 2.0 900
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
0.1% v/v Glacial acetic acid solution (pH
60 1000
50 41 mM Na2HPO4,3.1) 1.5% Citric Acid, pH 900
3.0 ± 0.5
50 0.1 N HCl 900
50 0.1 N HCl 900
50 mM phosphate buffer (pH 6.8) with
75 900
2% sodium lauryl sulfate (SLS)
Refer to USP
50 1% w/v Aqueous Sodium Dodecyl Sulfate 1000
Refer to USP 900
Refer to FDA's Dissolution Guidance,
2018
50 0.05 M SLS in water 900
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
60 Phosphate Buffer, pH 6.0 1000
Phosphate Buffered Saline solution, pH
100 100
7.0
Phosphate Buffered Saline solution, pH
100 200
7.0
0.5% SDS (Sodium dodecylsulfate) in
60 1000
water-pH adjusted to 6.5 ± 0.5
50 0.1 N HCl 900
50 0.1 N HCl 900
Develop a dissolution method
Refer to USP
75 Water
75 1% SLS in Water 900
25 Phosphate Buffer, pH 7.2 900
75 Water (deaerated) 900
75 0.09%
0.025 Sodium Lauryl Sulfate
M Na Acetate in 0.10.15%
Buffer with N HCl 500
75 Sodium Lauryl Sulfate [SLS] (pH 5.0) 500
0.025 M Sodium Acetate Buffer with
[degassed]
75 600
0.15% SLS, pH 5.0
50 0.1 M Phosphate Buffer, pH 4.5 900
Develop a dissolution method
50 0.05 M Phosphate Buffer, pH 7.2 900
50 0.2 M Acetate Buffer, pH 4.7 500
50 0.2 M Acetate Buffer, pH 4.7 500
50 0.1 N HCl 500
0.029 M sodium phosphate buffer w/
150 900
0.5% SDS, pH 7.4
150 pH 7.4 Phosphate Buffer with 0.5% SDS 900
75 0.1 N HCl containing 1% Sodium Lauryl 900
75 1% Sodium LaurylSulfate
Sulfate (SLS) in 0.01 N 900
HCl
100 0.01 N HCl 900
50 0.5% SDS in water 900
Refer to USP
50 Water(deareated) 900
50 0.1 N HCl 900
Refer to USP
100 Water 900
Refer to USP

Lamivudine and Zidovudine: Lamivudine and Zidovudine: 0.1 N HCl Lamivudine and Zidovudine: 1000
75 Efavirenz: 50 Efavirenz: 2% SLS in water Efavirenz: 900
Lamivudine and Zidovudine: water
50 ForNevirapine:
Risedronate0.06
Tablets: Refer 900
M HCl (pH to USP;
1.2)
For Calcium Carbonate Tablets: Refer to
USP.
"Citrate-sodium hydroxide" buffer pH Media 1: 750 mL pH 1.1±0.1;
180 6.8 (150 ml of 2N NaOH, 21.014 gm of Media 2: 950 mL pH 6.0±0.1;
citric acid and ultra-pure water to 1000 Media 3: 1000 mL pH 7.5±0.1
Refer to USP
Diclofenac: Acid Stage: 0.1 N HCl Buffer
Stage: 750ml 0.1N HCL+250ml 0.2M Diclo: Acid: 750 Buffer:1000
100 (diclo) 50 (miso) phos.buffer, pH 6.8 (Method A) Miso: 500
Misoprostol: Water (deaerated)
Refer to USP
Refer to USP
100 Acid stage: 0.06 N HCl; Buffer stage: 900
Neutralized Phthalate Buffer, pH 5.5
Buffer stage (B): Acid stage (A): 750 mL; Buffer
100 Phosphate Buffer, pH 6.4 stage (B): 950 mL; Buffer stage
Buffer stage (C): Phosphate Buffer, (C): 960 mL
Solution, pH 6.8Refer to USP
(After initial 120 mins.,
250 mL of 0.2 M sodium phosphate
solution is added to acid stage medium.
50 750 (Acid), 1000 (Buffer)
The pH of the mixture is adjusted to 6.8
using 0.2 M sodium phosphate, 2 N
mM
sodiumphosphate buffer,
hydroxide, pH 6.8 with 0.37
or concentrated HCl Acid Stage: 750 mL; Buffer Stage
75 % Polysorbate 80 (after 120 minutes, to
1000 mL
the acid stage, add 250 mL of 0.2M
hours add 300 mL of 0.6 M Tris buffer;
100 adjust to pH 8.0 (Buffer stage) with 2 N Acid stage: 700; Buffer stage:
1000
HCl or 2stage:
Acid N NaOH
HCl .0.1
Stabilize
N withthe samples
0.5% w/v
100 Macrogol Cetostearyl Ether; Buffer stage:
Acid
pHStage: 0.1 N HCl;
7.2 Sodium Buffer Stage:
Phosphate buffer 50
100 Acid Stage: 0.1 N HCl (degassed); Acid Stage: 900; Buffer Stage: 900
mM Potassium phosphate, pH Buffer
6.8
100 Stage: Phosphate Buffer, pH 6.8 Acid Stage: 900; Buffer Stage: 900
Acid stage: 0.06 N HCl; Buffer stage:
(degassed) Acid stage: 900 mL; Buffer stage:
100
Neutralized Phthalate Buffer, pH 5.5 900 mL
Refer to USP
Acid stage: 0.1 N HCl; Buffer stage: Acid stage: 300; Buffer stage:
100
Phosphate Buffer, pH 6.8 1000
Refer to USP
Refer to USP
100 Water 500
Acid stage: 0.1 N HCl; Buffer stage:
75 Acid stage: 500; Buffer stage: 500
Phosphate buffer, pH 6.8
Refer to USP
Acid stage: 0.1 N HCl: Buffer stage: 0.05
M Phosphate buffer, pH 6.8, with 0.15% Acid stage: 900 mL; Buffer stage:
100
sodium lauryl sulfate (SLS) [only for 900 mL
Acid Stage:Bisacodyl
0.1 N HCl; Buffer Stage: pH
Tablets]
100 Acid Stage: 500 mL; Buffer Stage:
7.2Acid
Phosphate Buffer with 5 mMStage:
Stage: 0.1 N HCl; Buffer Sodium
900 mL
75 lauryl sulfate
Phosphate Buffer, pH 6.8 with 5 mM 500 (Acid), 900 (Buffer)
Develop aSodium
method to characterize
Dodecyl Sulfate in vitro
release
Develop a dissolution method
Develop a dissolution method

50 Phosphate Buffer, pH 6.8 900

Acid Stage: 0.1 N HCl; Buffer Stage: Acid Stage: 900 mL; Buffer Stage:
75
Phosphate Buffer, pH 6.8 1000 mL
0.05 M Phosphate Buffer, pH 6.8 buffer,
100 pH 6.8 1000
100 0.1 N HCl 900
50 0.1 N HCl 900
100 0.01 N HCl 900
100 1% Phosphate Buffer, pH 6.0 500
Stage 2: 700 mL of 0.001N HCl for next 2
hours (add 200 mL of HCl to Stage 1); Stage 1: 500; Stage 2: 700; Stage
50
Stage 3: 900 mL of Phosphate Buffer, pH 3: 900
Acid
6.8 Stage:
(add 200 0.1
mL M of HCl containing
Potassium 0.5%
Phosphate
Macrogol Cetostearyl Ether; Buffer Stage: Acid Stage: 500 mL ; Buffer Stage:
100
pH 7.2 phosphate buffer containing 0.5% 1000 mL
Macrogol Cetostearyl Ether.
Refer to USP
75 0.1 N HCl 900
Refer to USP
100 0.1 N HCl 500
Row 1: Test Fluid 1 (0.1N HCl) for 1st
27 dpm hour. Row 2: Test fluid 2 (Phosphate Row 1: 250 mL. Row 2: 250 mL
Buffer, pH 7.5) for 5th hour
100 0.1 N HCl 900
50 0.1 N HCl 900
Refer to USP
Acid stage: 0.01 N HCl; Buffer stage:
50 Acid stage: 500; Buffer stage: 500
Phosphate Buffer, pH 7.0
100 Phosphate Buffer, pH 6.8 1000
0.01N HCl Comparative dissolution data
100 should also be provided in 900 ml pH 4.5 900
buffer, pH 6.8 buffer, and water using
FirstApparatus
hour: 0.1 NI (Basket)
HCl; at 100 RPM.
50 After 1 hour: 0.1M Potassium 1000
Phosphate
First hour: 0.1 N HCl;Buffer pH 7.5
50 After 1 hour: 0.1M Potassium 1000
Phosphate Buffer pH 7.5
100 0.9% NaCl in water 900
0.02N HCl (2 hours) followed by 0.05M
12 dpm Phosphate Buffer pH 7.5 250

50 0.01 N HCl 900


Refer to USP
100 Water (deaerated) 900
100 Phosphate Buffer, pH 5.8 900
75 SGF without enzyme 900

100 Phosphate Buffer, pH 6.8 900

Refer to USP
Refer to USP
50 Water (deaerated) 1000
10 mM Phosphate buffer at pH 7.4 with 500 (for 300 mg); 900 (for 600
50
1.0 % SLSFluid without
Simulated Intestinal mg)
50 900
pancreatin, pH 7.5
75 0.1 N HCl 900
50 0.01 N HCl 900
100 Simulated gastric fluid (SGF) without 900
enzyme (pH 1.2)
Refer to USP
Refer to USP
0.2% Lauryl Dimethylamine Oxide (LDAO)
50 1000
in water Oxide (LDAO)
0.2% Lauryl Dimethylamine
50 500
in water
100 0.05 M Phosphate Buffer, pH 6.0 900
Refer to USP
0.5% sodium lauryl sulfate (SLS) / sodium
50 For phosphate
Niacin: Water; for(0.01M),
Lovastatin: 900
buffer pH 0.05
6.5 M
100 phosphate buffer, pH 7.0 with 0.5% 900
sodium dodecyl
Refer to USPsulfate
Refer to USP
100 pH 2.1 Buffer (Degassed) 900
50 Water (degassed) 900
0.04 M Sodium phosphate buffer pH 6.8
75 900
containing 2% sodium lauryl sulfate
100 Water 900
Refer to USP
HCl with SLS (32.5 ± 0.1 g Sodium Lauryl
50 Sulfate in 6489 mL of purified water 900
containing 17.0 mL HCl, pH adjusted to
1.20 ± 0.05 with HCl)
Refer to USP
Refer to USP
Refer to USP
Refer to USP
50 0.06 M HCl 900
Refer to USP
50 Water 900
4.8) [solution A]. At 5 hrs, pH adjusted to
200 6.6 by addition of 100 mL of 0.05M 900 [solution A]. 1000 [final]
dibasic sodium phosphate and 0.46N
Refer to USP
Develop a dissolution method
SGF without Enzyme, pH 1.2 during 1st
hour. Phosphate Buffer at pH 7.5 from
50 end of hour 1 through the duration of 900
SGF without Enzyme, pH
testing 1.2 during 1st
hour. Phosphate Buffer at pH 7.5 from
50 900
end of hour 1 through the duration of
testing
75 0.1 N HCl 900
For Trandolapril: Water; For Verapamil:
For Trandolapril: 500; For
50 0-1 hour Gastric Fluid w/o Pepsin pH=1.2, Verapamil: 900
1-8mM
50 hourPhosphate
Intestinal Fluid w/o
buffer, pHPancreatin
6.8 [for 15
mg and 30 mg strengths]; 25 mM
100 900
Phosphate buffer with 2.75% NaCl, pH
6.8 for [45 mg strength]
50 0.1 M NaCl in water (Degassed) 900
Refer to USP
Refer to USP
3 Stage dissolution: 50 mM potassium
phosphate monobasic buffer at pH 4.0
100 900
(0-2 hours), 6.0 (2-4 hours) and 6.8 ( 4
hours and beyond)
Refer to USP
50 Acid stage: 0.01 N HCl; Buffer stage: Acid stage: 500; Buffer stage: 500
500 mLPhosphate
0.1N HCl for the 1st
Buffer, pHhour,
7.0 then
50 add 400 mL 0.27M Sodium Phosphate Acid stage: 500; Buffer stage: 900
50 (Dibasic) buffer
Phosphate solution
Buffer, pH 6.8 900
Refer to USP
75 HCl Buffer, pH 2.2 900
Hydrochlorothiazide: 0.1N HCl;
Hydrochlorothiazide: 100; Hydrochlorothiazide: 500;
Metoprolol succinate: Phosphate Buffer,
Metoprolol succinate: 75 Metoprolol succinate: 500
pH 6.8
30 cycles per min Water 50

Refer to USP
Simulated Gastric Fluid (SGF) without
100 900
900 enzyme
mL 0.1 N(pH
HCl1.2)
for (degassed)
one hour, then
replace the medium with 900 mL 0.05 M
75 phosphate buffer at pH6.8 containing 900
900 0.01%
mL 0.1sodium
N HCl for onesulfate.
lauryl hour, then
replace with 900 mL 0.05 M phosphate
50 900
buffer at pH 8.2 containing 0.01% sodium
lauryl sulfate
100 Phosphate Buffer, pH 6.8 1000
Refer to USP
100 Phosphate Buffer, pH 6.8 900
50 Water (deaerated) 900
100 Water 500
50 Phosphate Buffer, pH 7.5 900

Niacin: Water; Simvastatin: 0.5 % SDS in


100 900
0.01 M Sodium Phosphate, pH 7.0

Refer to USP
Refer to USP
50 45 mM Phosphate Buffer, pH 4.5 900
Modified SGF, pH 1.0 [NaCl (0.2% w/w) in
50 500
0.0825N HCl]
100 0.05 M phosphate buffer, pH 6.8 500
100 0.05pH
M 4.0 Citrate-THAM
Phosphate Buffer Buffer
of pH 6.8, 500
100 Simulated intestinal fluid (without 900
hour. SIF without enzyme from end of
enzyme)
100 hour 1 through the duration of the 900
50 Water 900
100 0.05 M Phosphate Buffer, pH 6.8 500
(deaerated)
50 Water (deaerated) 900
Refer to USP
Met: Simulated Gastric Fluid [SGF]
without enzyme, pH 1.2; Can: 0.1% (w/v)
polysorbate 20 in 0.05 M sodium
Met: 100: Can:100 Met: 900: Can: 900
phosphate buffer pH 6.8 ( 50 mg); 0.2%
(w/v) polysorbate 20 in 0.05 M sodium
phosphate buffer pH 6.8 (150 mg)
50 0.1 N HCl 900
Simulated gastric fluid (SGF) without
50 900
enzyme (pH 1.2)
15 mM hexadecyltrimethylammonium
25 dpm bromide (CTAB) in 0.03M Sodium 250
Phosphate Buffer, pH 6.8
Refer to USP
Acid stage: 0.1 N HCl: Buffer stage: 0.2M Acid stage: 1000 mL; Buffer stage:
100
sodium phosphate buffer pH 6.8 1000 mL
100 Phosphate Buffer, pH 6.8 900

75 Phosphate Buffer, pH 6.8 900


100 0.1 N HCl (deaerated) 900
Simulated Gastric Fluid [SGF] without
100 900
enzyme
75 1.0% SDS in Deionized Water (degassed) 900
Simulated Gastric Fluid [SGF, pH 1.2]
50 without enzyme 900
Refer to USP
0.005% HPC in Water with 0.50% SLS
100 900
0.1 M SDSadjusted
(sodium to pH 4.5sulfate) in
dodecyl
75 900
water
75 0.4M KH2PO4 solution (degas) 900
Acid Stage: 0.1 N HCl; Buffer Stage: Acid Stage: 900 mL; Buffer Stage:
75
Phosphate Buffer, pH 6.8 1000 mL
Phosphate buffer pH 6.8 with 0.5%
50 900
0.1 N HCl withTween 20
0.5% sodium dodecyl
75 900
sulfate (SDS), pH 1.1
50 0.1 N HCl 900
50 0.1 N HCl 900
70 mM Potassium Phosphate Buffer, pH
50 500
6.0
50 0.01 N HCl 500
75 Acetate Buffer, pH 4.0 1000
500 mL (10 mg) or 1000 mL
25 50 mM Acetate Buffer, pH 4.5
(20mg)
50 0.1 N HCl 750
50 Water 900
50 0.1 N HCl 900
50 0.1 M Phosphate Buffer, pH 4.5 900
50 0.001 N HCl 500
50 SGF without enzyme 900
50 Water 900
Refer to USP
Refer to USP
50 22 mM Sodium Acetate Buffer, pH 4.5 500
50 0.1 N HCl 500
50 Water 500
75 0.15% SDS Buffer, pH 6.8 900
50 0.1 N HCl 500
Refer to USP
50 RPM (12.5 mg, 25 mg and
100 mg); 75 RPM (150 mg pH 4.5 Acetate Buffer 900
and 200 mg)
500 mL (15 mg) or 900 mL (30 mg
50 Water
and 37.5 mg)
50 0.1 N HCl 900
Acid stage: 100; Buffer stage: Acid stage: 0.1 N HCl; Buffer stage: Acid stage: 300; Buffer stage:
75 Phosphate Buffer, pH 6.8 1000
Refer to FDA's Dissolution Guidance,
2018
50 0.1 N HCl 900
100 Water 500
100 Water 500
50 Phosphate Buffer, pH 6.8 500
50 Phosphate Buffer, pH 6.5 500
50 pH 4.5 Acetate Buffer 50
Simulated intestinal fluid (without
50 500
enzyme), pH 6.8, (deaerated)
75 Phosphate Buffer, pH 6.8 900
50 Acetate Buffer, pH 4.5 500
50 0.1 N HCl 900
Refer to USP
Refer to USP
100 Phosphate Buffer, pH 6.8 1000
50 Phosphate Buffer, pH 6.8 900
Refer to USP
75 0.01 N HCL 1000
Refer to USP
Refer to USP
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
Refer to USP
Develop dissolution method(s) to
characterize the dissolution of both
50 components
Simulated gastric fluid without pepsin. 900
75 0.01 N HCl 900
Refer to USP
150 0.01 N HCl 900
50 0.1 N HCl 900
2.5 and 5 mg tablets: 500 mL; 10,
50 Phosphate Buffer, pH 6.4 25, 50, 75 and 100 mg tablets:
900 mL
Refer to FDA's Dissolution Guidance,
0.01 N HCl with 2018
0.375% Triton X-100
75 (degassed) 900
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
Refer to USP
Refer to USP
Refer to USP

100 0.01 N HCl with 2% w/w Polysorbate 80 1000


Refer to FDA's Dissolution Guidance,
2018
Refer to USP
75 Phosphate Buffer, pH 6.8  with 0.75% Brij 1000
35
Refer to USP
75 0.5% Tween 20 in Phosphate Buffer, pH 900
6.8
Refer to FDA's Dissolution Guidance,
2018
50 0.05 M Phosphate Buffer, pH 6.8 900
Refer to FDA's Dissolution Guidance,
2018
Refer to USP
Phosphate buffer pH 6.8, saline with 0.03
50 900
Phosphate % ascorbic
Buffer, acidwith 0.45%
pH 6.8
100 900
Refer to(w/v)
FDA'sPolysorbate
Dissolution 80
Guidance,
2018
50 Phosphate Buffer, pH 6.8 (degas) 900
Rilpivirine (RPV): 0.5% Polysorbate 20 in
0.01 N HCl; Emtricitabine (ETC) and RPV: 1000 mL; ETC and TAF: 500
75
Tenofovir alafenamide (TAF): 50 mM mL
Sodium Citrate, pH 5.5,
0.5%(w/w) polysorbate 20 in 0.01N HCl
75 1000
(pH 2.0)
75 50 mM Sodium Citrate buffer, pH 5.5 500
Refer to USP
Refer to USP
Refer to USP
M HCl in two phases: Phase 1: 1000 mL
70 of degassed 0.01 M HCl for 10 minutes. 1000 (phase 1): 1800 (phase 2)
Phase 2: Add 800 mL of 2.25% SLS in
M HCl in two phases: Phase 1: 500 mL of
50 degassed 0.01 M HCl for 10 minutes. 500 (phase 1): 900 (phase 2)
Phase 2: Add 400 mL of 2.25% SLS in
75 0.01 N HCl 1000
50 0.05 M Phosphate Buffer, pH 7.2 900
75 0.05 M Phosphate Buffer, pH 6.0 900
75 0.75% Sodium lauryl sulfate in water 900
50 25 mM Sodium lauryl sulfate in water 1000
50 0.05 M Sodium lauryl sulfate in water 1000
Refer to USP
75 Water with 2% Tween 80 900
Mcilvaine Buffer (Citric Acid/Phosphate
50 900
Buffer),
Refer to FDA's pH 4.0 Guidance,
Dissolution
2018
Refer to USP
Refer to USP
Refer to USP
50 mM Potassium Phosphate Buffer, pH
50 900
6.5, (degassed)
50 0.1 N HCl 1000
75 0.1 N HCl 900
75 pH 4.5 sodium acetate buffer with 1% SLS 900
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
50 pH 1.8 KCl Buffer 900
Refer to FDA's Dissolution Guidance,
0.05M Sodium Phosphate
2018 Buffer, pH 6.8
75 with 0.3% (w/v) Polyoxyethylene 10 900
LaurylRefer
Etherto(POE10LE)
USP
Refer to USP
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
35 0.05 M Phosphate
Citrate-Phosphate Buffer,
buffer pH 6.8
(0.023M Citric 900
75 acid+0.026M Sodium Phosphate, 900
0.1M sodium phosphate
Dibasic), buffer pH 7.4
pH 4.0
75 1000
containing
0.1M sodium0.45% Sodium buffer
phosphate Lauryl pH
Sulfate
7.4
75 1000
containing 0.8% Sodium
0.5% Polysorbate 20 inLauryl
0.01NSulfate
HCl
75 900
Acetate Buffer(pH=2.0)
pH 4.5, 0.2% sodium
75 900
dodecyl sulfate (SDS)
75 Acetate Buffer pH 4.5, 0.4% SDS 900
75 Acetate Buffer pH 4.5 900
1.0% SDS (sodium dodecyl sulfate) in
50 1000
Phosphate Buffer, pH 6.8
75 0.01 N HCl 900
Refer to USP
75 Phosphate Buffer, pH 6.8[degassed] 900
Refer to FDA's Dissolution Guidance,
2018
50 Phosphate Buffer, pH 6.8 900
Refer to USP
Refer to FDA's Dissolution Guidance,
2018
Refer to FDA's Dissolution Guidance,
2018
50 Water 900
Refer to USP

Phosphate Buffer, pH 6.8 with 0.4%


20 dpm sodium dodecyl sulfate (SDS) [3 small 250
drops of antifoaming agent may be used]
Acid stage: 0.1 N HCl; Buffer stage: Acid stage: 750; Buffer stage:
75
Sodium phosphate buffer, pH 6.8
dissolved tablet & sinker to the vessel 1000
containing the buffer stage medium. Add,
Naproxen::Acid Stage: 1000;
Naproxen::50 rpm 10 mL of 10 M NaOH to each vessel of
Buffer Stage: 1000;
Esomeprazole::75 rpm the remaining acid stage medium.
Esomeprazole::900
Continue rotation at 100 rpm for 30
minutes, withdraw aliquot and analyze.
50 50 mM Sodium Acetate Buffer, pH 4.5 500
Refer to USP
Refer to USP
75 50 mM phosphate buffer (pH 6.8) with 900
2% sodium lauryl sulfate (SLS)
50 Phosphate Buffer, pH 6.8 (degas) 900
mM sodium phosphate, pH 6.8/ IVA:
FDC: ELE: 75/IVA: 65/TEZ:75; 0.4% (w/v) SLS in 50 mM sodium FDC: ELE: 900/IVA: 900/TEZ:900;
phosphate, pH 6.8/TEZ: 0.2% (w/v) SLS
IVA: 75 IVA 900
solution in 0.1N HCl; IVA: 1.8% (v/v)
Polysorbate
Buffer with 0.4%20 in 50 mM
Sodium sodium
Dodecyl Sulfate
FDC: IVA: 65/TEZ:75; IVA: 65 (SDS), pH 6.8/TEZ: 0.2 SDS% in 0.1 N HCl; FDC: IVA: 900/ TEZ: 900; IVA: 900
IVA: 50 mM Sodium Phosphate Buffer
RIB: 50; LET: 75 RIB: 0.01 N HCl; LET: 0.1 N HCl RIB: 900; LET: 900
Refer to FDA's Dissolution Guidance,
2018

50 pH 6.8 phosphate buffer at 32 ± 0.5°C 500

Acetic acid/sodium acetate buffer, pH 4.0


50 500
at 32ºC
Neutralized phthalate buffered solution
50 (0.2 M potassium biphthalate) with pH of 900
Develop a method to characterize
5.0 at 32 ± 0.5°C in vitro
release
50 Phosphate Buffer, pH 4.5 @ 32oC 900

50 pH 5.1 Acetate Buffer at 32°C 900


Refer to USP

50 Phosphate Buffer, pH 4.5 at 32°C 900


Stroke depth: 2-3 cm; 30-60 25 × 150 mm test-tubes
Distilled Water
cycles per minute containing 20 mL

50 0.1 M Phosphate buffer, monobasic, pH 5 500


at 32°C
0.1 M Phosphate buffer, monobasic, pH 5
50 1000
at 32°C
50 0.01 N HCl at 32ºC 900
0.25% Hydroxypropyl-Beta-Cyclodextrin
75 500
(HPCD) in Water
monohydrate (pH (Deaerated
~ 2.6). at 32°), C.
32±0.5˚C
Change
the test samples into fresh pre-
equilibrated release medium at the time 250 mL for the 75 and 100
30 cycles per minute. points indicated. Remove the protective mcg/hr, 200 mL for the 50 mcg/hr
amplitude of about 2m. liner and place the film onto a piece of and 150 mL for the 25 and 12.5
nylon netting with adhesive facing the mcg/hr dosage strength.
net. Secure the netting and transdermal
systemsodium
0.25% using nylon
dodecyltie sulfate
wraps at the in
(SDS) top
DI
50 900
water
50 Deionized Water 500
130 0.9% Saline 250
Develop a method to characterize in vitro
Develop a method release
to characterize in vitro
release
40 Phosphate Buffer, pH 4.75 ± 0.05 500
Recommended Sampling Times (minutes) Date Updated

5, 10, 15, 20 and 30 07/07/2022

1, 2, 4, 6, 10, 12 and 24 hours 01/03/2007

07/02/2020
10, 20, 30, 45 and 60 01/03/2007
09/22/2011
5, 10, 15 and 30 01/12/2004
01/05/2012
01/29/2010
5, 10, 15, 20, 30 and 45 10/21/2010
07/02/2020
10, 20 , 30, 45, and 60 06/20/2007
07/02/2020

1, 2, 3, 4, and 6 hours 08/17/2006

10, 15, 20, 30 and 45 02/09/2023


10, 15, 30, and 45 02/19/2008
5, 10, 15, 30 and 45 01/14/2004
10, 15, 20, 30 and 45 01/20/2006
05/28/2015
06/24/2010
08/27/2009
Acid: 10, 20, 30, 45 and 60 min; Buffer:1, 2, 5,
10/09/2007
and 7 hours
10, 20, 30 and 45 01/20/2006
07/02/2020
10, 20, 30, and 45 01/15/2004
12/22/2016
10, 20, 30, and 45 01/26/2006
12/24/2015
02/09/2023
07/02/2020

15, 30, 45 and 60 08/17/2006

5, 15, 20, 30 and 45 10/06/2008


10, 20, 30, 45, 60 and 75 01/31/2013
Acid stage: 2 hours; Buffer stage: 0.25, 0.5, 1,
02/25/2015
2, 4, 6 and 8 hours
06/03/2008
07/02/2020
5, 10, 15, 20, 30 and 45 06/30/2016
03/03/2011
07/02/2020
5, 10, 15, 30 and 45 07/25/2007
10, 20, 30, 45 and 60 08/15/2013

10, 20, 30, 45 and 60 07/01/2010

07/02/2020
5, 10, 15, 20 and 30 08/27/2015
07/02/2020
03/02/2017
10, 20, 30 and 45 10/06/2008
07/02/2020
07/02/2020
05/09/2013
10, 20, 30 and 45 01/24/2004

10, 20, 30, and 45 09/22/2011

10, 15, 20, 30 and 45 05/28/2015


06/18/2007
10, 20, 30, 40 and 60 01/27/2004
07/25/2007
5, 10, 15, 20 and 30 01/05/2012
5, 10, 20, 30 and 45 06/25/2015
10, 15, 20, 30 and 45 10/21/2010
06/18/2007
10, 20, 30 and 45 01/14/2008
09/03/2008
07/02/2020
07/02/2020
06/03/2008
07/02/2020
5, 10, 15, 30, 45, 60, and until at least 80% of
01/31/2007
the labeled content is released
07/02/2020
Dutasteride: 15, 30, 45 and 60 minutes.
Tamsulosin: Acid Stage: 2 hours 01/26/2012
Buffer stage: 0.5, 1, 2, 3, 5, 7 and 10 hours

15, 30, 45 and 60 03/22/2006

07/02/2020
07/02/2020
15, 20, 30, 45, 60 and 75 08/19/2021

10, 15, 20, 30 and 45 05/28/2015

15, 30, 45, 60 and 90 08/05/2010


07/02/2020

10, 20, 30, 45 and 60 01/30/2020

10, 20, 30 and 45 07/15/2009


5, 10, 20, 30, 45, 60 and 75 02/15/2018
07/02/2020
06/24/2010
5, 10, 15, 20 and 30 08/19/2021
15, 30, 45, 60, 90 and 120 02/19/2008
11/25/2008
5, 10, 20, 30 and 45 01/30/2020
10, 20, 30, 45 and 60 01/29/2004
5, 10, 15, 20 and 30 08/15/2013
07/02/2020
07/02/2020
10, 20, 30 and 45 08/17/2006
01/31/2013
01/14/2008
07/02/2020
10, 20, 30, 45 and 60 02/02/2004
07/02/2020
10/06/2008
07/02/2020
04/02/2009
5, 10, 20, 30 and 45 06/25/2015
5, 10, 15, 20 and 30 06/25/2015
10, 20, 30 and 45 01/03/2007

10, 20, 30 and 45 03/04/2006

08/15/2013

30, 60, 90, 120, 150 and 180 01/14/2008

10, 15, 20 and 30 02/04/2004


5, 10, 15, 20 and 30 05/28/2015
05/28/2015
04/22/2021
10, 20, 30, 45 and 60 02/25/2004
10, 20, 30, 45, 60 and 90 02/04/2004
10, 20, and 30 02/09/2023
10, 15, 20, 30 and 45 04/15/2008
5, 10, 15, 20 and 30 12/24/2015
07/02/2020
07/02/2020
5, 10, 20, 30 and 45 06/25/2015
12/24/2015
5, 10, 15, 20 and 30 07/07/2022
07/02/2020
12/15/2009
5, 10, 15, 20 and 30 06/30/2016
03/25/2010
07/31/2013
07/02/2020
02/15/2018
04/22/2021
5, 10, 15, 20, 30 and 45 11/02/2017
10, 20, 30 and 45 01/03/2007
07/02/2020
04/15/2008
5, 10, 20 and 30 02/10/2004
15, 30, 45 and 60 07/14/2008
10, 15, 20, 30 and 45 05/28/2015
Netupitant: 10, 20, 30, 45, 60 and 75;
Palonosetron: 5, 10, 15, 20, 30 and 45 09/03/2015

10, 20, 30 and 45 02/11/2004


03/03/2011
10, 15, 30 and 45 10/30/2009
10, 20, 30, and 45 04/09/2007
10, 15, 20, 30, 45 and 60 09/03/2015

10, 15, 20, 30, 45 and 60 11/02/2017

5, 10, 15, 20, 30 and 45 11/02/2017


04/02/2009
01/14/2008
09/03/2015
10, 20, 30 and 45 02/12/2004
15, 30, 45 and 60 07/14/2008

5, 10, 15, 20, 30 and 45 05/12/2022

10, 20, 30, 45 and 60 02/12/2004


07/02/2020
07/02/2020
05/12/2022
07/02/2020
20, 30, 45, 60 06/18/2007
07/02/2020
07/02/2020
07/02/2020
5, 15, 30, 45 and 60 04/15/2008
07/02/2020
04/10/2008
07/02/2020
06/18/2007
07/02/2020
10/04/2012
10, 15, 20, 30 and 45 05/28/2015
10, 20, 30, 45 and 60 07/07/2022
05/12/2022
07/02/2020
04/08/2010
01/14/2008
07/02/2020
10, 20, 30 and 45 02/18/2004
10, 20, 30 and 45 02/18/2004
12/15/2009
07/02/2020
01/15/2015
07/02/2020
09/13/2007
07/02/2020
5, 10, 15, 20 and 30 07/07/2022
10, 20, 30, 45 and 60 07/07/2022
04/09/2008
10, 20, 30, 45 and 60 02/25/2004
07/02/2020
10, 15, 20, 30 and 45 05/28/2015
5, 10, 15 and 30 07/14/2008
07/07/2022
06/18/2007
10, 20, 30, 45, 60 and 90 02/20/2004
07/02/2020
30, 60, 90 and 120 02/20/2004

5, 10, 15, 20, 30 and 45 04/22/2021

5, 10, 15, 20, 30 and 45 04/22/2021

10, 15, 20, 30 and 45 08/27/2020


1, 2, 3, 6, 8, and 10 hours 03/26/2007
07/02/2020
01/14/2008
07/02/2020
10, 20, 30, 45, 60 and 90 02/20/2004
10, 15, 20, 30 and 45 08/19/2021
07/02/2020
10, 20, 30, 60 and 90 03/04/2006
15, 30, 45 and 60 12/03/2007

5, 10, 15, 20 and 30 02/09/2023

07/02/2020
5, 10, 20, 30 and 45 04/27/2009
10, 15, 20, 30 and 45 08/05/2010
07/02/2020
07/02/2020
5, 10, 15, 20 and 30 11/02/2017
12/15/2009
10, 20, 30 and 45 12/13/2004
07/02/2020
10, 15, 20, 30 and 45 05/28/2015
10, 20, 30, 45 and 60 02/09/2023
5, 15, 30, 45 and 60 09/03/2008
07/02/2020
10, 20, 30 and 45 02/19/2004

10, 20, 30, 45 and 60 03/04/2006


Acid stage: 60, 90 and 120; Buffer stage: 10, 01/26/2004
20, 30, 45 and 60
08/27/2015
Amoxicillin/Rifabutin: 5, 10, 15, 20 and 30;
Omeprazole: Acid Stage: 120; Buffer Stage: 5, 08/27/2020
10, 15, 20 and 30;
Acid stage: 120; Buffer stage: 15, 30, 60, 90,
07/01/2010
120, 240
Acid stage: 2 hours; and 360
Buffer stage: : 5, 10, 15,
08/27/2015
20 and 30 minutes
Acid Stage: 120; Buffer Stage: 10, 20, 40, 50, 08/05/2010
60 , 75,
Acid Stage: 120; 105Stage:
Buffer and 120
10, 20, 30, 45, 04/02/2020
60, 75 and 90
1, 2, 2.5 , 3 and 4 hours 10/06/2008

11/04/2008
Phase 1: 120; Phase 2: 60; Phase 3: 20, 30,
06/30/2016
45, 60, 75, 90 and 120
Acid Stage: 120; Buffer Stage: 15, 30, 45, 60,
08/27/2020
90, 120 and 150
Acid stage: 120; Buffer stage: 10, 20, 30 45
04/22/2021
and 60
06/18/2007
Acid Stage: 120; Buffer Stage: 10, 15, 20, 25,
05/15/2014
30 and 45
06/30/2016
03/17/2016
03/17/2016
1, 2, 5, 7, 9, 12 and 14 hours 01/15/2010
0.5, 1, 2, 3, and 4 hours 07/25/2007

0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours 11/16/2017

1, 4, 8, 12, 18 and 24 hours 04/02/2009


1, 4, 12, and 24 hours 11/25/2008
0.5, 1, 2, 4, 6, and 10 hours 01/14/2008
1, 4, 8 and 12 hours 11/25/2008
02/19/2008
02/19/2008
02/19/2008
11/04/2008
Donepezil: 5, 10, 15, 20 and 30 minutes;
05/28/2015
Memantine: 1, 2, 3, 4, 6, 8, 10 and 12 hours
1, 2, 4, 6, 8 and 12 hours 01/15/2010

1, 4, 10 and 12 hours 01/20/2006

1, 2, 4, 6, 8, 10 and 12 hours 05/28/2015


07/25/2007
06/25/2015
1, 2, 4, 6, 8, 12, 16, 20 and 24 hours 05/28/2015
Acid stage: 0.5, 1 and 2 hours; Buffer stage: 05/12/2022
0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours
06/10/2009
Acid stage: 2 hours; Buffer 06/10/2009
stage: 0.5, 1, 2, 4, 7 and 9 hours
1, 2, 4, 6, 8, 12 hours and until at least 80%
04/15/2008
released
0.5, 1, 3, 6, 8 and 10 hours 07/25/2007
08/11/2008
0.5 , 2 and 6 hours 07/14/2008
1, 2, 4, 6 and 8 hours 06/10/2009
11/02/2017
07/25/2007
10/06/2008
1, 3, 7 hours 06/18/2007
0.5, 1, 2, 4, 6 and 8 hours 06/25/2015
1, 2, 3, 4, 6 and 8 hours 08/14/2014
0.5, 1, 2, 3, 5, 7, 9, 12, 16, 20 and 24 hours 09/03/2015

2, 3, 4, 6, 8, 12 and 16 hours 07/15/2010

2, 4, 8, 12 and 20 hours 01/03/2007


08/27/2015
1, 2, 4, 6, 8, 10, 12 and 16 hours 07/07/2022
1, 2, 3, 6, 9, 12, 16, 22 and 30 hours 10/20/2016
1, 2, 4, 6, 8, 10 and 12 hours 10/20/2016
1, 2, 4, 6, 8, 10 and 12 hours 09/01/2011
1, 2, 4, 6, 8, 12, 18 and 24 hours 10/31/2013
10/20/2016
1, 2, 3, 4, 6, 8, 10 and 12 hours 03/02/2017
0.5, 1, 2, 4, 6, and 10 hours 10/20/2016
Acid Stage: 0.5, 1, 2, 4, 6 hours; Buffer Stage:
04/02/2020
1, 2, 4, 6, 8 and 10 hours
0.25, 0.5, 1.0, 1.5, 2, 3 and 4 hours 06/02/2016
1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24 hours 08/14/2014
Morphine Sulfate: Acid stage: 1 hour; Buffer
stage: 1, 3, 5, 8 and 10 hours. Naltrexone HCl: 01/26/2012
Acid stage: 1 hour; Buffer stage: 1, 12, 24, 48,
73 and 96 hours.
12/22/2016
1, 2, 4, 6, 8, 12, 16, 20 and 24 hours 07/28/2016
Phentermine: 10, 15, 20, 30 and 45;
06/06/2013
Topiramate: 0.5, 1, 2, 3, 4, 6 and 8 hours
12/24/2015
10, 20, 30, 45, 60 and 90 01/14/2008
10, 20, 30, 40 and 60 06/03/2008
5, 10, 15, 20, 30 and 45 02/08/2018
5, 10, 15, 20, 30 and 45 01/15/2015

15, 30, 45 and 60 08/05/2010

10, 15, 30 and 45 06/18/2007

15, 30, 45, 60, 90 and 120 08/19/2010


10, 20, 30, 45 and 60 02/28/2013
5, 10, 20 and 30 02/04/2004
5, 10, 20, 30 and 45 05/09/2013
10, 20, 30, 45 and 60 02/19/2004
10, 20, 30, 45 and 60 05/15/2014
10, 20, 30, 45, 60, 75 and 90 03/17/2016
5, 10, 15, 20 and 30 06/02/2016
5, 10, 15, 20 and 30 03/17/2016
5, 10, 15, 30 and 45 04/14/2016
03/17/2016

10, 20, 30, 45, 60, 75 and 90 03/17/2016

5, 10, 15, 20 and 30 03/17/2016


07/02/2020
10, 20, 30, 45 and 60 06/02/2016

03/17/2016

10, 15, 20, 30 and 45 03/17/2016

15, 30, 45, 60, and 90 minutes 03/17/2016

10, 20, 30 and 45 01/03/2007


5, 10, 15, 20 and 30 12/22/2016
5, 10, 15, 20 and 30 10/20/2016
07/02/2020
Acid stage: 2 hours; Buffer stage: 5, 10, 20,
06/02/2016
30 and 45
Acid stage: 30, 60 and 120 minutes; Buffer
stage: 15, 30, 60, 90, 120, 180 and 240 04/07/2016
minutes

02/28/2013

02/28/2013

10, 20, 30, 45 and 60 01/14/2008


07/21/2009
07/25/2007

10, 20, 30 and 45 01/03/2007

5, 10, 20 and 30 01/05/2012

Acid stage: 60, 90 and 120; Buffer stage: 10,


20, 30, 45 and 60 10/30/2009
1, 2, 4, 6 hours and until 80% of drug
01/14/2008
released
1, 2, 3, 6, 8, 12, 16 and 24 hours 06/30/2011

2, 5, 10, 15, 20 and 30 04/22/2021

10, 15, 20, 30, 45 and 60 10/20/2016

5, 10, 15, 20, 30 and 45 12/15/2009

5, 10, 15, 20, 30 and 45 12/15/2009

5, 10, 15, 20 and 30 01/26/2012

2.5, 5, 7.5, 10, 12.5, 15 and 20 08/19/2021

1, 2, 3, 5, 7 and 10 10/31/2013

0.25, 0.5, 1, 2, 4, 8, 12, 16, 20 and 24 hours 05/20/2009

1, 2, 4, 7, 9 and 12 hours 06/10/2009

0.5,1, 2, 4, 6, 8,12, 16 and 24 hours 05/09/2013


10/28/2010

10/28/2010

1, 2, 4, 6, 8, 10 and 12 hours 10/28/2010

6, 12, 18, 24, 36, 48, 60, 72 and 96 hours 10/28/2010

1, 2, 4, 6, 10, 12, 18, 24 and 36 hours 10/31/2013

1, 3, 5, 7, 11, 16, 20 and 24 hours 06/30/2011

2, 6, 12, 24, 36, 48, 60, 72 and 96 hours 03/03/2011


01/31/2013

10, 20, 30, 45, 60, 90, 120 and 180 04/08/2010

10, 15, 30, 60, 120, 180, 240, 300, 360, 420
and 480 06/25/2015

10, 20, 30, 45, 60, 75, 90, 105, 120, 150, 180,
12/24/2015
240, 360, 480, 600, and 720

1, 8, 24, 96, and 168 hours 11/16/2017

5, 10, 15, 20 and 30 01/03/2007


5, 10, 15, 20 and 30 10/04/2012
15, 30, 45 and 60 02/09/2023
Acid stage: 120; Buffer stage: 10, 20, 30, 45 09/02/2010
and 60
5, 10, 15, 20, 30 and 45 06/06/2013
5, 10, 15 and 20 03/17/2016
5, 10, 15, 20 and 30 02/09/2023
07/20/2017
15, 30, 45, 60, 90 and 120 02/09/2023
Acid stage: 120; Buffer stage: 10, 20, 30, 45
02/07/2019
and 60
Acid stage: 120; Buffer stage: 5, 10, 15, 20,
07/07/2022
30 and 45
0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours 01/30/2020
0.5, 1, 2, 3, 5 and 10 minutes 03/02/2017
07/07/2022
5, 10, 15, 30 and 45 04/02/2009
07/28/2016
5, 10, 15, 20 and 30 11/02/2017
5, 15, 20 and 30 09/24/2008
0.5, 1, 1.5, 2, 2.5, 3, 3.5 and 4 hours 11/16/2017
10, 15, 20, 30, 45 and 60 07/07/2022
Acid Stage: 2 hours; Buffer Stage: 1, 2, 3 and
07/14/2008
4 hours
Acid Stage: 120; Buffer Stage: 5, 10, 15, 20
08/27/2020
and 30

0.5, 1, 2, 3, 4, 6 and 8 hours 07/07/2022


09/02/2010

0.25, 0.5, 1, 2, 4, 6, 8 and 10 hours 05/12/2022


1, 4, 12, 24, 36, 48, 72, 96, 120, 144 and 168
07/28/2016
hours

3, 14, 35, 56 and 84 days (10.8 mg strength);


11/04/2008
7, 14, 17, 21 and 28 days (3.6 mg strength)

05/12/2022
12, 24, 48, 72, 96, 120, 144, 168, 192, 216
10/21/2010
and 240 hours
08/19/2021

01/15/2010

08/14/2014
12/22/2016

01/15/2010

12/23/2010

10/04/2012

07/28/2016
09/03/2008
5, 10, 15, 30, 45, 60, 90, 120, 180, 240, 300,
04/08/2010
and 360
1, 6, 12, 24, 48 and 72 hours 07/14/2008

5, 10, 15, 20, 30, 45, 60 and 75 03/17/2016

Test 1: 5, 10, 15, 20, 30, 40, 50, 60, 70, 80


and 90; Test 2: 5, 10, 15, 30, 60, 90, 120, 240, 10/31/2013
360, 1440 and 2880

02/08/2018

15, 30, 45, 60, 90 and 120 10/08/2009


09/01/2011

01/15/2010

1, 2, 4, 8, 12, 16, 24, 36, 48, 72, 96 and 120


02/08/2018
hours
1.5, 5, 8, 10, 15, 20, 30 and 45 09/01/2011
5, 30, 60, 90, 120, 180, 240, 300 and 360 03/17/2016
02/14/2014
10/06/2008
0.5, 1, 2, 3, 6 and 8 hours 12/23/2010

15, 30, 45, 60 and 90 03/09/2017

5, 10, 20, 30 and 40 05/20/2009


01/15/2015
02/15/2018
04/02/2009
06/30/2016
08/14/2014
06/30/2016
09/01/2011
01/31/2013
05/15/2014
06/30/2016
07/21/2009
10, 20, 30, and 45 08/17/2006
10, 20, 30 and 45 03/25/2010
5, 10, 15, 20, 25 and 30 07/31/2013
5, 10, 15, 20, 30 and 45 06/25/2015
02/14/2014
5, 10,15 and 20 12/03/2007
10, 20, 30 and 45 10/28/2010
10, 20, 30 and 45 10/28/2010
10, 20, 30, 45, 60, 75 and 90 06/25/2015
12/15/2009
5, 10, 15, 20 and 30 12/24/2015
10, 20, 30, 45 and 60 10/21/2010
5, 10, 20, 30, 45 and 60 10/28/2010
5, 10, 15, 20 and 30 07/15/2009
10, 20, 30 and 45 12/03/2007
15, 30, 45, 60 and 90 08/17/2006
Sampling started at the buffer stage 10, 20,
01/03/2007
30, 45 and 60
Acid stage: 120; Buffer stage: 10, 20, 30, 45
02/28/2013
and 60
Acid stage: 120; Buffer stage: 10, 20, 30, 45 02/08/2018
and 60
09/01/2011
03/17/2016
03/17/2016
11/25/2008
5, 10, 15, 20, 30, 45 and 60 08/19/2021
5, 10, 15, 20, 30 and 45 08/19/2021
5, 10, 15, 20 and 30 11/16/2017
15, 30, 45, 60 and 90 04/02/2009
10, 20, 30, 45, 60 and 75 01/31/2013
2.5, 5, 7.5 and 10 10/21/2010
5, 10, 15, 20, 30, and 45 09/13/2007
0.25, 0.5, 1, 2, 3, 4, 6 and 8 hours 06/02/2016
5, 10, 15, and 30 06/20/2007
5, 10, 15, and 30 06/18/2007
08/26/2021

10, 20, 30 and 45 08/17/2006

10/20/2016
1, 2, 4, 8, 12, 16, 24, 36 and 48 hours 07/07/2022
15, 30, 45, 60 and 90 08/17/2006

30, 60, 90, 120 and 150 01/30/2006

15, 30, 45 and 60 10/08/2009

15, 30, 45, 60, 90, 120 and 150 10/08/2009

10, 20, 30, 45 and 60 02/20/2004


5, 10, 15 and 30 01/14/2004
10, 20, 30, 45 and 60 01/20/2004
5, 10, 15, 30 and 45 07/25/2007
10, 20, 30 and 45 04/09/2007
10, 20, 30 and 45 04/09/2007
10, 20, 30 and 45 12/20/2005
5, 10, 15 and 30 01/21/2004
10, 20, 30 and 45 01/21/2004
5, 10, 20, and 30 07/25/2007
03/07/2019
10, 20, 30, 45 and 60 01/23/2004
5, 10, 15, 20 and 30 05/28/2015
5, 10, 15 and 20 09/03/2008
5, 10, 15, 20 and 30 07/28/2022
4, 8, 12, 15 and 20 10/20/2016
10, 20, 30, 45 and 60 01/27/2004
10, 15, 30 and 45 11/25/2008
5, 10, 15 and 30 01/28/2004
10, 20, 30 and 45 11/25/2008
10, 20, 30 and 45 01/30/2004
10, 20, 30 and 45 01/30/2004
04/02/2009
11/04/2008
5, 10, 15 and 30 02/04/2004
10, 20, 30 and 45 01/14/2008
5, 10, 15 and 30 01/26/2006
5, 10, 20 and 30 02/10/2004
11/16/2017
10, 20, 30, 45 and 60 02/11/2004
10, 15, 20, 30 and 45 12/22/2016
15, 30, 60, 120 and 180 04/02/2009
10, 20, 30 and 45 02/12/2004
10, 20, 30 and 45 02/13/2004
5, 10, 15, 20 and 30 12/22/2016
06/18/2007
5, 10, 20, 30, 45 and 60 05/12/2022
5, 10, 15, 20 and 30 08/15/2013
5, 10, 15, 20 and 30 05/28/2015
10, 15, 20, 30 and 45 12/22/2016
5, 10, 15, 20 and 30 07/07/2022
10, 20, 30 and 45 03/04/2006
10, 20, 30, 45, 60 and 90 02/25/2004
10, 20, 30 and 45 01/03/2007
5, 10, 15, 20, 30, 40 and 60 10/20/2016
15, 30, 45, 60, 120 and 180 04/15/2008
Acid Stage: 1 hour; Buffer Stage: 1, 2, 4, 6, 8
03/17/2016
and 12 hours
30, 60, 90 and 180 10/06/2008
0.5, 1, 2, 3, 4, 6, 8 and 12 hours 06/02/2016
12/22/2016
03/07/2019
07/07/2022
5, 10, 15 and 20 11/04/2008
07/02/2020
Abacavir and lamivudine: 10, 15, 20, 30 and
05/28/2015
45; Dolutegravir: 5,15, 25, 35 and 45.
10, 20, 30, and 45 01/03/2007
5, 10, 15, 30 and 45 01/03/2007
5, 10, 15, 20 and 30 11/16/2017
10, 20, 30, 45 and 60 02/28/2013
10, 15, 20, 30 and 45 03/22/2006
07/02/2020
06/25/2015
15, 30, 45, 60 and 90 01/03/2007
01/14/2008
10, 15, 30, 45 and 60 07/25/2007
08/15/2013
5, 10, 15, 20, and 30 02/09/2023
01/14/2008
10, 20, 30, 45 and 60 01/12/2004
01/15/2010
01/15/2010
5, 10, 15, 20 and 30 03/04/2006
07/14/2008
06/18/2007
07/02/2020
07/02/2020
07/02/2020
07/02/2020

10, 15, 20, 30 and 45 11/25/2008

07/02/2020
10, 15, 20, 30 and 45 06/07/2012

10, 15, 20, 30 and 45 06/07/2012

10, 15, 20, 30 and 45 10/08/2009


07/25/2007
07/02/2020
07/02/2020
5, 10, 15, 20 and 30 11/19/2015
07/02/2020
07/02/2020
07/02/2020
5, 10, 15, 30, and 45 05/20/2009
08/19/2021
08/19/2021
07/02/2020
06/07/2012
08/27/2015
10, 20, 30, 45, 60 and 90 01/12/2004
10, 20, 30, 45, 60 and 90 01/12/2004
01/14/2008
07/02/2020
5, 10, 15 and 30 04/02/2009
10, 20, 30 and 45 08/11/2008
Telmisartan: 10, 15, 20, 30 and 45;
08/05/2010
Amlodipine: 10, 15, 20, 30 and 45
07/02/2020

10, 20, 30 and 45 11/25/2008

07/02/2020
5, 10, 15, 20, 30, and 45 07/28/2022
5, 10, 20, 30 and 45 05/09/2013
10, 15, 20, 30, and 45 05/18/2017
10, 20, 30 and 45 01/14/2008
06/24/2010
10, 20, 30, 45 and 60 01/15/2004
10, 20, 30, 45, 60 and 90 01/15/2004
10, 20, 30, 45, 60 and 90 01/15/2004
10, 20, 30, 45, 60 and 90 01/15/2004
01/15/2010
Atazanavir: 10, 15, 20, 30 and 45; Cobicistat:
5, 10, 15, 20 and 30 12/24/2015
5, 10, 15 and 30 01/15/2004

5, 10, 15, 20, 30 and 45 05/15/2014

10, 20, 30, 45, 60 and 90 06/18/2007

15, 30, 45 and 60 08/17/2006

5, 10, 15, 20, 30, 45, 60, 90 and 120 05/12/2022


04/08/2010
5, 10, 15, 20, 30 and 45 05/09/2013
5, 10, 15, 20, 30 and 45 05/09/2013
12/15/2009
10, 15, 20, 30 and 45 02/09/2023
10, 20, 30, 45, 60, 75, 90 and 120 07/31/2013
5, 10, 15, 20 and 30 08/19/2021
5, 10, 15, 20, 30, and 45 08/19/2021
10, 20, 30 and 45 01/16/2004
10, 20, 30 and 45 01/16/2004
07/25/2007
07/02/2020
10, 20, 30, 45 and 60 01/16/2004
07/02/2020
10/06/2008
10, 20, 30, 45 and 60 12/15/2005
07/02/2020
5, 10, 20, 30 and 45 01/20/2004
15, 30, 45 and 60 09/02/2010
10, 15, 20, 30 and 45 10/20/2016
5, 10, 15, 20, 30 and 45 11/02/2017
07/25/2007
07/14/2008
07/02/2020
07/02/2020
5, 10, 15 and 30 07/14/2008
07/02/2020
5, 10, 15, 20, 25 and 30 07/07/2022
07/02/2020
01/14/2008
5, 10, 15, 20 and 30 06/02/2016
Canagliflozin: 10, 15, 20, 30 and 45;
Metformin: 5, 10, 15, 20 and 30 05/28/2015

10, 20, 30, 45 and 60 06/20/2007


10, 20, 30, 45 and 60 06/20/2007
10, 20, 30, 45 and 60 01/29/2010

15, 20, 30, 45 and 60 01/29/2010

11/02/2017
07/02/2020
5, 10, 15, 20, 30 and 45 05/12/2022
07/02/2020

10, 20, 30, 45 and 60 01/03/2007

04/22/2021
05/12/2022
01/29/2010
12/24/2015
10, 20, 30 and 45 01/21/2004
5, 10, 15 and 30 07/07/2022
09/02/2010
5, 10, 15, 20 and 30 01/15/2010
07/25/2007
07/25/2007
10/04/2012
07/25/2007
5, 10, 15, 30, 45, 60 05/12/2022
5, 10, 15, 20 and 30 04/22/2021
10, 20, 30, and 45 08/17/2006
04/16/2020
5, 10, 15, 20 and 30 06/25/2015
10, 20, 30 and 45 02/20/2004
04/15/2008
01/14/2008
15, 30, 45, 60 and 90 08/17/2006
10, 20, 30 and 45 01/26/2006
09/02/2010
07/02/2020
5, 10, 15, 20 and 30 05/12/2022
07/25/2007
5, 10, 20, 30, 45 and 60 07/31/2013
07/02/2020
06/18/2007
07/02/2020
01/31/2013
5, 10, 15, 20 and 30 08/27/2015
Cobi: 5, 10, 15, 20 and 30; Drv: 10, 15, 20, 30
and 45 10/20/2016

5, 10, 15, 20 and 30 10/20/2016

07/02/2020
08/05/2010

10/28/2010

07/25/2007
10, 20, 30, 45 and 60 01/24/2004
07/02/2020
07/02/2020
08/27/2020
15, 30, 45, 60, 75 and 90 01/30/2020
10, 20, 30, and 45 09/13/2007
Drv: 10, 15, 20, 30 and 45; For Cobi, Emt and
07/07/2022
Taf: 5, 10, 15, 20 and 30
10, 15, 30 and 45 10/30/2009
07/02/2020
Acid Stage: 2 hours; Buffer Stage: 1, 2, 3 and 07/07/2022
4 hours
5, 10, 15, 20 and 30 11/16/2017
10, 20, 30, 45 and 60 12/03/2007
07/25/2007
07/02/2020
07/02/2020
07/02/2020
11/04/2008

0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours 11/02/2017

07/02/2020
07/02/2020
07/02/2020
10, 20, 30, 45 and 60 01/31/2013
07/25/2007
10, 20, 30, 45, 60 and 90 01/27/2004
05/12/2022
10, 15, 20, 30 and 45 06/07/2012
04/15/2008
06/18/2007
10, 20, 30 and 45 01/14/2008
06/18/2007
15, 30, 45, 60, 75, 90, 105, and 120 06/18/2007
07/01/2010
10, 15, 20, 30, 45 and 60 02/08/2018
5, 10, 15, 20, 30 and 45 10/18/2018
5, 10, 15, 20, 30 and 45 10/18/2018
5, 10, 15, 20, 30 and 45 10/18/2018
10, 20, 30, 45 and 60 01/27/2004
5, 10, 15, 20, 30 and 45 09/02/2010
07/02/2020
07/02/2020
10, 15, 20, 30, 45, 60, 90 and 120 02/25/2015
10, 20, 30, and 45 01/03/2007
10, 15, 30, 45, 60 06/18/2007

10, 20, 30, and 45 01/03/2007

5, 10, 15, 20 and 30 08/19/2021


5, 10, 15, 20, 30 and 45 04/22/2021
5, 10, 15 and 30 04/02/2009
10, 15, 20, 30, 45, and 60 06/07/2012

10, 20, 30, 45 and 60 12/24/2015

07/02/2020
10, 15, 20, 30 and 45 12/24/2015
5, 10, 15, 30 and 45 01/03/2007
09/03/2008
10, 20, 30 and 45 01/29/2004
07/02/2020
5, 10, 15, 20, 30 and 45 05/12/2022
07/02/2020
15, 30, 45 and 60 07/14/2008
10, 20, 30 and 45 02/19/2008
5, 10, 15, 20, 30 and 45 10/18/2018
12/24/2015
04/22/2021
07/02/2020
5, 10, 15, 20, 30 and 45 08/27/2015
10, 20, 30 and 45 01/27/2004
15, 30, 45, 60, 90, 120 and 180 02/19/2008
10, 20, 30 and 45 07/09/2004
1, 2, 3, 5, 8, 10 and 12 hours 09/02/2010
12/24/2015
2, 5, 8 and 12 hours 10/06/2008
07/02/2020
01/14/2008
10, 20, 30 and 45 07/14/2008
02/19/2008
02/19/2008
11/04/2008
07/15/2009
07/15/2009
5, 10, 20 and 30 01/14/2008
10, 20, 30 and 45 01/14/2008
10, 20, 30, 45, 60 and 90 01/28/2004
10, 20, 30, 45 and 60 01/31/2013
06/18/2007
01/14/2008
10, 20, 30 and 45 07/01/2010
10, 20, 30 and 45 08/17/2006
10, 20, 30 and 45 01/14/2008
5, 10, 20 and 30 01/03/2007
07/02/2020
02/09/2023
08/15/2013
5, 15, 30, 45 and 60 08/05/2010
10, 20, 30, 45 and 60 08/27/2015
5, 10, 20, 30 and 45 02/19/2004
07/02/2020
5, 10, 15, 20 and 30 02/09/2023
5, 10, 20 and 30 01/29/2004
07/02/2020
07/02/2020
5, 10, 15, 20 and 30 06/07/2012
05/20/2009
11/02/2017
07/02/2020
10, 20, 30 and 45 12/16/2005
10, 20, 30 and 45 01/30/2004
08/11/2008
07/02/2020
08/05/2010
07/02/2020
07/02/2020
08/11/2008
10, 20, 30, 45 and 60 10/28/2010
07/25/2007
10, 20, 30 and 45 01/03/2007
10, 15, 20, 30 and 45 08/27/2020
5, 10, 15 and 30 07/23/2004
For Pioglitazone: 10, 15, 20, 30 and 45;
For Glimepiride: 10, 04/02/2009
15, 20 and 30
5, 10, 15, 30, 45 and 60 01/03/2007
08/05/2010
12/18/2008
10, 20, 30, 45 and 60 02/02/2004
10, 20, 30, 45 and 60 02/02/2004
01/14/2008
07/02/2020
07/02/2020
01/15/2010
11/04/2008
08/19/2021
11/25/2008
10/30/2009
07/02/2020
07/02/2020
10, 20, 30 and 45 09/24/2008
10, 20, 30, 45 and 60 02/03/2004
10, 20, 30, 45 and 60 02/03/2004
5, 10, 15 and 30 02/10/2004
5, 10, 15, 20, 30, 45 and 60 07/09/2007
5, 10, 20 and 30 02/03/2004
08/27/2009
07/31/2013
5, 10, 15 and 30 02/04/2004
05/09/2013
07/02/2020
04/16/2020
07/07/2022
07/02/2020
07/02/2020
10, 15, 20, 30 and 45 02/09/2023
10, 20, 30, 45 and 60 04/02/2020
10, 20, 30, 45 and 60 04/02/2020
07/25/2007
10, 20, 30 and 45 04/09/2007
5, 10, 15, 20 and 30 08/27/2015
5, 10, 15, 30, 45 and 60 08/05/2010
07/02/2020
04/15/2008
08/11/2008
10, 20, 30, 45 and 60 02/04/2004
04/15/2008
07/02/2020
08/19/2021
5, 10, 15 and 30 02/04/2004
5, 10, 15, 20 and 30 08/19/2021
07/02/2020
5, 10, 15, 20 and 30 06/25/2015

5, 10, 15, 20 and 30 03/17/2016

10, 20, 30, 45 and 60 02/04/2004


10, 15, 20, 30 and 45 08/27/2020
15, 30, 45, 60 and 90 01/03/2007
10, 20, 30, 45 and 60 02/05/2004
07/02/2020
07/02/2020
07/02/2020
07/02/2020

5, 10, 15, 20, 30 and 40 01/03/2007

10, 15, 20, 30 and 45 10/20/2016


10, 20, 30, 45 and 60 01/03/2007
11/02/2017
10, 15, 30, 45 and 60 01/03/2007
10, 15, 30 and 45 10/30/2009
05/12/2022
5, 10, 15, 20, 30, 45 and 60 08/27/2015
10, 20, 30, 45, 60, 75, and 90 04/22/2021
10, 20, 30 and 45 02/05/2004
10, 20, 30 and 45 05/31/2007
5, 10, 15, 20 and 30 05/12/2022
10, 15, 20, 30, 45 and 60 02/08/2018
07/02/2020
07/02/2020
07/02/2020
08/27/2015
07/02/2020
10, 20, 30, 45, 60 and 90 02/05/2004
04/22/2021
07/25/2007
5, 10, 15, 20, 30 and 45 05/15/2014
07/02/2020
06/18/2007
07/02/2020
07/02/2020
10, 20, 30 and 45 02/05/2004
07/02/2020
10, 15, 20, 30 and 45 08/27/2015
01/14/2008

5, 10, 15, 20 and 30 01/31/2013

10, 15, 20, 30 and 45 05/28/2015


5, 10, 15 and 20 02/09/2023
07/02/2020
10, 15, 20, 30 and 45 02/09/2023
07/02/2020
10, 20, 30, 45 and 60 08/27/2009
12/24/2015
10, 20, 30, 45 and 60 02/06/2004
10, 20, 30, 45 and 60 02/20/2004
07/02/2020
07/02/2020
07/02/2020
11/25/2008
20, 30, 45, 60, 90 and 120 02/06/2004
5, 10, 15, 20 and 30 02/09/2004
03/25/2010
10/20/2016
07/02/2020
10, 20, 30 and 45 01/03/2007
10, 15, 20 and 30 10/06/2008
5, 10, 15, 20 and 30 10/30/2009
07/02/2020
10, 15, 20, 30 and 45 05/28/2015
01/14/2008
04/02/2009
02/15/2018
07/02/2020
07/02/2020
01/29/2010
10, 20, 30, 45, 60 and 75 07/31/2013
07/15/2009
04/02/2020
07/02/2020
07/02/2020
07/02/2020
5, 10, 15, 20 and 30 01/14/2008
07/02/2020
07/02/2020
04/15/2008
07/02/2020
5, 10, 20 and 30 02/10/2004
06/10/2009
10, 20, 30, 45 and 60 02/10/2004
07/02/2020
07/02/2020
5, 10, 20 and 30 04/09/2007
07/02/2020
07/02/2020
5, 10, 15 and 30 02/10/2004
07/25/2007
07/02/2020
07/02/2020
07/02/2020
07/02/2020
07/25/2007
10/04/2012
5, 10, 15, 20 and 30 06/25/2015
5, 10, 15, 20, 30 and 45 05/28/2015
10, 15, 20, 30 and 45 07/01/2010
07/02/2020
10, 20, 30 and 45 01/03/2007
10, 20, 30 and 45 01/15/2010
5, 10, 15, 20 and 30 10/20/2016
10, 20, 30, 45 and 60 01/03/2007
5, 10, 15, 20, 30, 45, 60 and 90 01/03/2007
15, 30, 45 and 60 01/14/2008
09/13/2007
15, 30, 45, 60, 90 and 120 02/09/2023
10, 20, 30, 60 and 75 07/07/2022
05/20/2009
10, 20, 30, 45, 60 01/03/2007
10, 15, 20, 30, 45, 60, 75 and 90 02/15/2018
10/08/2009
08/27/2009
15, 30, 45, 60 and 90 01/03/2007
5, 10, 15, 20, 30 and 45 11/02/2017
07/02/2020
07/02/2020
11/02/2017
Ombitasvir, paritaprevir, ritonavir: 10, 20, 30,
45, 60, 90, 120 and 150; Dasabuvir: 5, 10, 15, 08/27/2015
20 and 30
07/02/2020
08/19/2021
07/02/2020
10, 20, 30, 45, 60 and 75 06/02/2016
02/09/2023
10, 20, 30, 45, 60 and 90 02/12/2004
10, 20, 30, 45, 60 and 90 02/12/2004
10, 20, 30, 45, 60 and 90 02/12/2004
07/02/2020
10, 15, 20, 30 and 45 08/19/2021
10, 20, 30, 45 and 60 06/02/2016
07/02/2020
07/02/2020
10, 15, 30, 45 and 60 08/05/2010
5, 10, 15, 20, 30 and 45 05/12/2022
10, 20, 30, 45, 60 and 90 02/13/2004
06/24/2010
5, 10, 15, 20 and 30 05/15/2014
10, 20, 30 and 45 03/04/2006
10, 20 , 30 and 45 06/20/2007
07/02/2020
07/02/2020
10, 20, 30 and 45 03/25/2010
07/02/2020
03/25/2010
07/02/2020
02/19/2008
07/02/2020
5, 10, 15 and 30 02/13/2004
07/02/2020
10, 15, 20, 30, 45 and 60 09/03/2015
08/05/2010
07/02/2020
07/02/2020
06/25/2015
11/25/2008
12/24/2015
5, 10, 15, 20, 30 and 45 04/22/2021
07/02/2020
01/14/2008
10, 20, 30, 45, 60, 75, and 90 04/22/2021
07/02/2020
11/02/2017
04/22/2021
07/02/2020
07/02/2020
01/14/2008
04/22/2021
01/15/2010
07/02/2020
07/02/2020
06/25/2015
10, 20, 30 and 45 02/18/2004
07/02/2020
10, 20, 30 and 45 02/18/2004

15, 30, 45, 60 and 120 04/02/2009

07/02/2020
07/02/2020
07/25/2007
07/02/2020
10, 15, 20, 30 and 45 06/25/2015
5, 10, 15, 20 and 30 07/07/2022
07/25/2007
10, 20, 30 and 45 02/18/2004
10, 20, 30, 45 and 60 05/12/2022
10, 20, 30, 45, 60 and 90 02/25/2004
10, 20, 30, 45 and 60 02/18/2004
10, 20, 30, and 45 01/03/2007
5, 10, 15, 20 and 30 12/24/2015
5, 10, 15, 20, 30 and 45 05/12/2022
07/01/2010
10, 20, 30, 45 and 60 03/04/2006
01/15/2015
07/02/2020
10, 15, 20, 30 and 45 10/20/2016
05/15/2014
07/02/2020
07/02/2020
5, 10, 15, 30, 45 and 60 11/02/2017
07/02/2020
10, 20 , 30 and 45 09/13/2007
10, 15, 20, 30 and 45 08/19/2021
10, 15, 20, 30, 45, 60 and 75 08/19/2021
10, 20, 30 and 45 02/20/2004
10/06/2008
04/09/2008
5, 10, 15 and 30 03/04/2006
06/18/2007
5, 10, 15, 20 and 30 08/19/2021
10, 20, 30, 45, 60 and 120 03/14/2007
07/02/2020

5, 10, 15, 20, 30, and 45 10/31/2013

20, 30, 45, 60 and 90 01/15/2010

5, 10, 15, 20 and 30 08/19/2021


5, 10, 15, 20 and 30 10/20/2016
07/02/2020
5, 10, 15, 20 and 30 08/19/2021
5, 10, 15, 20 and 30 06/10/2009
04/15/2008
15, 30, 45, 60, 180, 240 and 480 04/02/2009
07/14/2008
01/14/2008
12/15/2009
07/02/2020
5, 10, 15, 20, 30 and 45 09/03/2015
10, 20, 30 and 45 01/26/2006
5, 10, 20, 30, 45 and 60 08/27/2020
04/02/2009
07/02/2020
5, 10, 15, 20, 30 and 45 05/12/2022
5, 10, 15, 20 and 30 06/02/2016
5, 10, 15, 20 and 30 07/07/2022
5, 10, 15, 20 and 30 05/09/2013
15, 30 and 45 04/02/2009
10, 20, 30 and 45 01/03/2007
5, 10, 15, 20, 30 and 45 08/19/2021
10, 20, 30, and 45 01/03/2007
10, 20, 30, 45 and 60 02/20/2004
10, 20, 30 and 45 02/20/2004
5, 10, 15, 20, 30 and 45 05/15/2014
5, 10, 15, 30 and 45 09/01/2011
07/02/2020
07/15/2009
07/02/2020
10, 20, 30, 45, 60 and 75 06/25/2015
10, 20, 30, 45 and 60 02/19/2004
07/02/2020
07/02/2020
5, 10, 15, 20 and 30 11/02/2017
07/02/2020
07/02/2020
05/09/2013
07/02/2020
10, 15, 20, 30 and 45 02/14/2014
07/02/2020
10, 20, 30 and 45 02/20/2004
5, 10, 15 and 30 02/20/2004
1, 2, 3, 4, 6, 8 and 10 hours 07/07/2022
07/02/2020
5, 10, 15, 20 and 30 12/24/2015
10, 20, 30, 45 and 60 02/20/2004
07/02/2020
07/02/2020
5, 10, 15, 20 and 30 08/27/2020
01/29/2010
07/02/2020
10, 15, 20, 30 and 45 05/12/2022
5, 10, 15, 20 and 30 01/31/2013
04/15/2008
07/02/2020
07/02/2020
5, 10, 15, 20 and 30 06/25/2015
07/02/2020
07/02/2020
10, 15, 20, 30 and 45 05/28/2015
07/02/2020
11/04/2008
5, 10, 15, 20 and 30 07/07/2022
02/09/2023
07/02/2020
10, 15, 20, 30 and 45 08/14/2014
5, 10, 20, 30, 45 and 60 12/24/2015
10, 20, 30 and 45 11/25/2008
10, 15, 20, 30 and 45 05/28/2015
5, 10, 20, 30 and 45 07/28/2022
01/29/2010
10. 30, 30 and 45 10/09/2007
02/19/2008
07/02/2020
10, 20, 30, 45 and 60 02/19/2004
07/02/2020
07/02/2020
1, 2, 3, 5, 7, 9 and 12 hours 08/27/2015

3, 5, 7.5, 10, 15 and 20 11/20/2009


3, 5, 7.5, 10, 15 and 20 11/20/2009

1, 2, 4, 6, 8, 10 and 12 hours 10/28/2010


5, 10, 15, 20 and 30 01/14/2008
10, 15, 20, 30 and 45 03/17/2016
05/12/2022
01/14/2008
10, 20, 30 and 45 02/09/2023
15, 30, 45, 60 and 90 12/23/2010
10, 15, 20, 30, and 45 12/23/2010
10, 20, 30 and 45 01/26/2004
10, 15, 20, 30 and 45 01/14/2008
10, 15, 20, 30 and 45 12/24/2015
10, 15, 20, 30 and 45 02/14/2014
10, 20, 30, 45 and 60 01/29/2004
12/15/2009
10, 20, 30 and 45 02/04/2004
5, 10, 15, 20 and 30 06/25/2015
5, 10, 15, 20 and 30 02/09/2023
15, 30, 45 and 60 07/14/2008
15, 30, 45, and 60 02/19/2008
15, 30, 45, 60 and 90 10/06/2008
15, 30, 45, 60, 90 and 120 10/06/2008
5, 10, 15, 30, 45 and 60 minutes 12/22/2016
10, 20, 30, 45 and 60 04/08/2010
5, 10, 20 and 30 03/04/2006
01/14/2008
5, 10, 15, 20 and 30 05/28/2015
10, 15, 20, 30, 45 and 60 11/02/2017
03/03/2011
15, 30, 45 and 60 03/25/2010
01/15/2015

10, 20, 30, and 45 01/03/2007

10, 15, 30, 45 and 60 01/03/2007


07/01/2010

120 (Acid) 30, 60, 90, 120, and 180 (buffer) 12/20/2005

06/10/2009
Diclo.: 120 (acid) 15, 30, 45 and 60 (Buffer).
Miso:10, 20 and 30 12/15/2005

07/25/2007
05/28/2015
Acid stage: 5, 10, 15, 20 and 30; Buffer stage: 05/28/2015
5, 10, 15, 20 and 30
Acid stage (A): 2 hours; Buffer
stage (B): 1 hour; Buffer stage (C): 06/10/2009
1, 2, 4, 6 and 8 hours
11/05/2010

120 (Acid), 10, 20, 30, 45 and 60 (Buffer) 12/19/2008

Acid Stage: 120; Buffer Stage: 10, 15, 20, 30


06/25/2015
and 45
Acid stage: 120; Buffer stage: 10, 20, 30, and 09/22/2011
45
Acid Stage: 2 hours; Buffer Stage: 1, 2, 3 and
04/22/2021
4 hours
Acid Stage:120; Buffer Stage:10, 20, 30, 45
07/07/2022
and 60
Acid Stage:120; Buffer Stage:10, 20, 30, 45,
12/22/2016
Acid stage: 10, 60
20,and
30, 75
45 and 60; Buffer
03/27/2018
stage: 5, 10, 15, 20, 30 and 45
10/31/2013
Acid stage: 120; Buffer stage: 10, 20, 30, 45
10/20/2016
and 60
12/15/2009
07/21/2009
1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8 and 10 hours 07/31/2013
Acid stage: 120; Buffer Stage: 10, 15, 20, 30
01/26/2012
and 45
12/15/2009
Acid stage: 60; Buffer stage: 10, 20, 30, 45
03/02/2017
and 60
Acid Stage: 120; Buffer Stage: 10, 15, 20, 30, 07/28/2016
50, 60, 75 and 90
60 (Acid), 10, 20, 30 and 45 (Buffer) 11/04/2008
07/07/2022
07/28/2016
04/08/2010

1, 1.5, 2, 2.5, 3, 4, 6 and 8 hours 07/28/2016

Acid Stage: 10, 15, 30, 45, 60, 90, 120; Buffer
07/28/2016
Stage: 5, 10, 15, 30 and 45
1, 2, 3, 5, 7, 10, 12, 16, 20 and 24 hours 08/19/2021
0.25, 0.5, 1, 2, 4, 6 and 8 hours 11/19/2015
1, 2, 4, 6, 9 and 12 hours 04/09/2007
1, 2, 12, 20 hours 06/18/2007
1, 4, 8, 12 and 16 hours 02/08/2007

1, 3, 3.17, 3.25, 3.5, 3.75, 4, 6, 8 and 12 hours 05/12/2022

Acid Stage: 2 hours; Buffer Stage: 1, 2, 4, 6, 8


04/02/2015
and 10 hours
07/25/2007
1, 2, 4, 6, 8 and 10 hours 06/10/2009
01/14/2008
0.17, 0.25, 0.5, 1, 2, 6 and 8 hours 06/18/2007
1 hour for test fluid 1, and 4 hours for test
07/25/2007
fluid 2
1, 2, 4, and 7 hours or until at least 80%
01/14/2008
released
15, 30, 60, and 120 01/14/2008
10/06/2008
Acid stage: 1 and 2 hours; Buffer stage: 1, 2,
08/27/2015
4, 6, 10, 14 and 16 hours
Dapagliflozin: 5, 10, 15, 20, 30 and 45
minutes: Metaformin: 0.5, 1, 2, 3, 4, 6, 8, 10 08/27/2015
and 12 hours
1, 4, 8, 12, 16, 20 and 24 hours 01/20/2006
For Desloratadine: 10, 20, 30 and 45; For
04/02/2009
Pseudoephedrine Sulfate: 1, 2, 6 and 8 hours
For Desloratadine: 10, 20, 30 and 45; For
Pseudoephedrine Sulfate: 1, 2, 4, 8, 16 and 04/02/2009
24 hours
1, 2, 4, 8, 12, 16, 20 and 24 hours 04/02/2009

0.5, 1, 2, 3, 4, 6 and 8 hours 05/28/2015

1, 2, 6, and 12 hours 11/25/2008


06/10/2009
1, 3, 5, 7 and 9 hours 05/20/2009
2, 8, 14, and 24 hours 02/19/2008
1, 2, 4, 6, 8, 12 and 16 hours 01/03/2007
Metformin: 1, 2, 4, 6, 8, 10 and 12 hours:
Empagliflozin and Linagliptin: 10, 15, 20, 30, 04/02/2020
45 and 60 minutes
01/14/2008
04/02/2009
0.5, 2, 4, 6 and 8 hours 09/22/2011
0.5, 1, 2, 4, 6, 8, 12 and 24 hours 01/31/2013
1, 2, 4, 8, 16 hours and until at least 80%
04/10/2008
dissolved
1, 2, 4, 6 and 12 hours 01/03/2007
1, 2, 6, and 12 hours 11/25/2008
1, 2, 4, 8, 12, 16, 20 and 24 hours 04/14/2016
06/25/2015
11/25/2008
2, 4, 8, 12, 16 and 24 hours 02/25/2004
2, 4, 8, 12, 16 and 24 hours 02/25/2004
1, 2, 4, 6, 8 and 12 hours 04/02/2009
01/14/2008
1, 2, 4, 6, 8, 12, 16 and 20 hours 02/07/2019
For Niacin: 0.5, 1, 2, 3, 6, 9, 12, 20 and 24
hours; For Lovastatin: 15, 30, 45 and 60 min 01/14/2008
12/12/2008
07/25/2007
15, 30, 45, 60, 90, 120, 180 and 210 11/02/2017
0.5, 1, 1.5, 2, 3, 4, 6 and 8 hours 09/03/2015
1, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 20 hours 01/31/2013
1, 3, 6, 9, 12, 15, 20 and 24 hours 06/10/2009
07/25/2007

1, 4, 8, 12, 15, 18 and 24 hours 04/02/2009

12/24/2015
11/19/2015
02/09/2023
07/25/2007
1, 2, 4, 6, 8, 10, 12, 16 and 24 hours 02/08/2018
01/14/2008
1, 2, 4, 6, 8 and 12 hours 06/10/2009

1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 hours 01/31/2013

04/22/2021
02/07/2019

1, 4, 8, 12 hours 10/06/2008

1, 4, 8, 12 hours 10/06/2008

2, 4, 8, 10 and 16 hours 01/03/2007


For Trandolapril: 5, 10, 20, 30 and 45; For
Verapamil: 1, 2, 3.5, 5 and 8 hours 12/19/2008

1, 2, 4, 6, 8, 12 and 16 hours 02/09/2023

1, 2, 4, 6, 8, 12, 14 and 16 hours 02/09/2023


01/05/2012
03/03/2011
0.25, 0.5, 1, 2, 2.25, 2.5, 3, 4, 4.25, 4.5, 5 and
10/21/2010
6 hours
03/03/2011
Acid stage: 1 and 2 hours; Buffer stage: 1, 2, 01/26/2012
4, 6, 10, 14 and 16 hours
1, 2, 3, 6, 9, 12, 16, 20 and 24 hours 07/01/2010
0.5, 1, 2, 4, 6, 8, 10 and 12 hours 06/07/2012
06/24/2010
1, 2, 4, 6, 8, 10, 12, 16, 20 and 24 hours 07/01/2010
Hydrochlorothiazide: 10, 15, 20, 30, and 45
minutes; Metoprolol succinate: 1, 2, 4, 6, 8, 10/31/2013
12, 16, 20 and 24 hours
1, 2, 4, 6, 8, 10, 12, 16, 20 and 24 hours 05/26/2016

02/18/2016
Linagliptin 10, 15, 20, 30 and 45 minutes;
07/28/2016
Metformin: 1, 2, 4, 6, 8 and 12 hours
Loratadine:10, 15, 20, 30 and 45;
Pseudoephedrine: 1, 2, 4, 8, 12, 16, 18 and 08/05/2010
24 hours
Loratadine:15, 20, 30, 45, 60 and 90;
08/05/2010
Pseudoephedrine: 1, 2, 4, 8, 12 and 16 hours
Metformin: 1, 2, 3, 4, 6, 8, 10 and 12 hours. 01/26/2012
Saxagliptin: 5, 10, 15, 20 and 30 minutes
02/14/2014
1, 3, 5, 7, 8.5, 10 and 12 hours 05/09/2013
1, 2, 3, 6, 9 and 12 hours 12/23/2010
1, 2, 4, 6, 8, 10 and 12 hours 12/23/2010
0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 14 hours 04/08/2010

Niacin: 1, 3, 6, 9, 12, 15, 18, 20 and 24 hours;


01/15/2010
Simvastatin: 10, 20, 30, 45 and 60

08/27/2009
03/17/2016
1, 2, 4, 6, 8 and 10 hours 02/14/2014
1, 2, 4, 6, 8, 12, 14, 18 and 24 hours 08/27/2009
1, 2, 4, 6, 9, 12, 16, 20 and 24 hours 09/02/2010
1, 2, 4, 6, 8, 12, 16, 20 and 24 hours 08/27/2009
0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours 10/31/2013
1, 2, 4, 8, 12 and 24 hours 10/06/2008
1, 2, 3, 5, 8, 10, 12, 16, 20 and 24 hours 03/02/2017
1, 2, 4, 6, 8, 12, 16, 20 and 24 hours 06/02/2016
1, 2, 4, 6, 8, 12, 16, 20 and 24 hours 02/14/2014
06/24/2010

Met: 1, 2, 4, 6, 8 10 and 12 hours: Can: 10,


12/22/2016
15, 20, 30, 45 and 60 minutes;

0.5, 0.75, 1, 1.5, 2, 2.5, 3 and 4 hours 08/15/2013


0.5, 1, 2, 4, 6, 8 and 12 hours 10/20/2016
Ombitasvir/ Paritaprevir/ Ritonavir: 10, 15,
20, 30, 45, 60 and 90 minutes;Dasabuvir: 1, 10/20/2016
2, 3, 6, 9, 12, 15, 18, 21 and 24 hours
06/30/2016
Acid stage: 5, 10, 15, 30, 60, 120 minutes;
01/19/2017
Buffer stage: 5, 10, 15, 20 and 30 minutes
Metformin: 1, 2, 4, 6, 8, 10 and 12 hours:
Empagliflozin: 10, 15, 20, 30, 45 and 60 01/19/2017
minutes;
1, 2, 4, 6, 8, 10, 12, 16 and 20 hours 08/15/2013
1, 2, 4, 5, 8 12, 16 and 20 hours 10/20/2016
0.25, 0.5, 1, 1.5, 2, 4, 6 and 8 hours 10/20/2016
1, 2, 4, 6, 8 and 10 hours 08/15/2013
0.25, 0.5, 1, 2, 4, 6, 8, 10 and 12 hours 12/22/2016
06/09/2011
0.5, 1, 2.5, 4.5, 6.5, 8.5 and 12 hours 06/30/2016
1, 2, 4, 6, 8, 10 and 12 hours 08/15/2013
0.25, 0.5, 1, 2, 3, 4, 6, 8 hours 03/17/2016
Acid Stage: 15, 30, 60, 120 minutes; Buffer
11/16/2017
Stage: 1, 2, 3, 4, 6 and 8 hours
10, 20, 30 and 45 06/21/2006
5, 10, 15, 20 and 30 11/16/2017
10, 20, 30 and 45 03/04/2006
5, 10, 15, 20 and 30 03/04/2006
2, 5, 10, 15 and 20 10/06/2008
5, 10, 15 and 20 10/06/2008
10, 20, 30 and 45 08/11/2008
5, 10, 15 and 30 07/14/2008
5, 10, 15, 30, and 45 07/25/2007
5, 10, 15, 30, and 45 07/25/2007
3, 6, 10, 15 06/18/2007
2, 5, 10, 15 and 20 10/06/2008
5, 10, 15, 30 and 45 09/03/2008
2, 4, 6 and 10 07/14/2008
5, 10, 15, 20, 30 and 45 04/08/2010
01/15/2015
06/18/2007
5, 15, 30, 45 and 60 09/03/2008
5, 10, 15 07/23/2004
5, 10, 15 and 20 10/06/2008
5, 10, 15 and 30 09/03/2008
5, 10, 15, 20 and 30 06/18/2007
03/17/2016

5, 10, 15, 20, and 30 06/09/2011

5, 10, 15, 20 and 30 07/31/2013


5, 10, 15 and 30 05/15/2014
Acid stage: 120; Buffer stage: 5, 10, 20, 30
04/22/2021
and 45
07/02/2020
5, 10, 15, 20 and 30 03/04/2006
2, 5, 8, 10, 15, and until at least 80% of the
labeled content is dissolved 04/09/2007
1, 3, 5, 7.5, 10, 15 and 20 07/01/2010
1, 3, 5, 7, 10, 15 and 20 08/15/2013
1, 3, 5, 8, and 10 01/15/2010
2, 4, 8, 12 and 15 05/12/2022
1, 3, 5, 7, 10 and 15 08/14/2014
1, 3, 5, 7, 10 and 15 08/14/2014
1, 2, 3, 4 and 5 05/09/2013
10, 20, 30 and 45 01/24/2004
07/21/2011
08/15/2013
5, 10, 15, 20, 30 and 45 12/23/2010
5, 10, 15, 20, 30 and 45 07/21/2011
07/28/2016
5, 10, 15, 20 and 30 03/17/2016
07/28/2016
10/04/2012
06/30/2016
07/02/2020
02/14/2014
12/22/2016
5, 10, 15, 20 and 30 04/02/2015
5, 15, 30, 45 and 60 08/14/2014
12/22/2016
10, 15, 20, 30 and 45 06/06/2013
10, 15, 20, 30 and 45 06/25/2015

5, 10, 15, 20 and 30 07/28/2016

07/02/2020
5, 10, 15, 20 and 30 07/28/2016
12/24/2015
07/02/2020
07/02/2020
07/02/2020
01/05/2012
08/15/2013
07/21/2011

5, 10, 15, 20 and 30 06/25/2015

07/02/2020
09/01/2011
10, 15, 20, 30 and 45 03/17/2016
12/23/2010
5, 10, 15, 20 and 30 03/17/2016
07/02/2020
1, 2, 3, 4, 6, 8 and 10 hours 12/23/2010
07/02/2020
07/28/2016
5, 10, 15, 20 and 30 07/28/2016
10, 15, 20, 30, 45 and 60 07/28/2016
07/02/2020
5, 10, 15, 20 and 30 06/30/2016

5, 10, 15, 20, 30 and 45 07/28/2016


Emtricitabine and Tenofovir: 5, 10, 15, 20
and 30; Rilpivirine: 10, 20, 30, 45, 60, 75, 90 01/15/2015
and 120
5, 10, 15, 20, 30 and 45 07/28/2016
01/05/2012
12/23/2010
09/22/2011
Phase 1: No Sampling. Phase 2: 5, 06/30/2011
10, 20, 30, 45, 60 and 90
Phase 1: No Sampling. Phase 2: 5,
08/14/2014
10, 20, 30, 45, 60 and 90
5, 10, 15, 20 and 30 08/15/2013
5, 10, 15, 20, 30 and 45 08/15/2013
5, 10, 15, 20 and 30 08/15/2013
5, 10, 20, 30, 45 and 60 10/21/2010
5, 10, 20, 30, 45 and 60 10/21/2010
5, 10, 20, 30, 45 and 60 10/21/2010
03/17/2016
10, 15, 30, 45 and 60 04/14/2016
5, 10, 15, 20 and 30 06/30/2016
07/02/2020
01/05/2012
06/30/2016
07/28/2016
10, 15, 20, 30 and 45 01/05/2012
5, 10, 15, 20 and 30 09/22/2011
5, 15, 30, 45, 60, 75 and 90 08/15/2013
10, 20, 30 and 45 03/17/2016
07/02/2020
07/02/2020
07/02/2020
07/02/2020
07/02/2020
07/02/2020
07/02/2020
10, 15, 20, 30 and 45 03/17/2016
07/02/2020
10, 20, 30, 45, 60, 90, 120, 150 and 180 06/30/2016
03/17/2016
06/09/2011
06/09/2011
07/02/2020
5, 10, 15, 20, 30 and 45 12/23/2010
10, 15, 20, 30 and 45 10/04/2012
10, 20, 30, 45, 60, 90 and 120 07/21/2011
10, 20, 30, 45, 60, 90 and 120 07/21/2011
10, 20, 30, 45 and 60 08/15/2013
10, 15, 20, 30 and 45 01/15/2015
10, 15, 20, 30 and 45 01/15/2015
10, 15, 20, 30 and 45 02/07/2019
5, 10, 15, 20, 30 and 45 08/15/2013
5, 10, 15, 20 and 30 01/19/2017
08/15/2013
10, 15, 20, 30 and 45 10/24/2019
07/02/2020
5, 10, 15, 20 and 30 03/17/2016
01/05/2012
07/02/2020
07/02/2020
15, 30, 45, 60, 90 and 120 12/23/2010
07/28/2016

0.25, 0.5, 0.75, 1, 1.5, 2, 3, 3.5 and 4 hours 07/28/2016

Acid stage: 2 hours; Buffer stage: : 5, 10, 20,


06/02/2016
30 and 45 minutes
Naproxen:: Acid stage: 120; Buffer stage: 10,
20, 30, 45, 60, 75 and 90; Esomeprazole::10, 06/06/2013
20, 30, 45, 60, 75 and 90

5, 10, 15, 20 and 30 05/12/2022


05/12/2022
02/09/2023
5, 10, 15, 20 and 30 07/28/2022
2.5, 5, 10, 15 and 20 03/02/2017

5, 10, 15, 20 and 30 08/19/2021

5, 10, 15, 20, 30 and 45 03/07/2019

5, 10, 15, 20, 30 and 45 03/07/2019


07/02/2020

15, 30, 45, 60, 90, 120 and 180 10/21/2010

10, 20, 30, 60, 120 and 180 01/03/2007

10, 20, 30, 60, 120, 150 and 180 01/31/2013


03/25/2010

1, 4, 24 hours 01/03/2007

1, 2, 3, 4, 6, 8, 10 and 12 hours 04/22/2021


02/18/2009

15, 30, 60, 90, 120, 150 and 180 07/15/2009


1, 2, 4, 6, 12, 18, 24, 36, 48, and 72 hours 07/15/2009

1, 2, 4, 8, 12, 16, 20 and 24 hours 07/15/2009

1, 2, 4, 8, 12, 16, 20 and 24 hours 07/15/2009


0.5, 1.5, 3, 4 hours and until at least 80%
04/15/2008
released
1, 2, 4, 6, 12, 24, 36, 48, 72 and 96 hours 05/12/2022

0.5, 1, 2, 4 and 24 hours 06/09/2011

5, 10, 15, 20 and 30 10/04/2012


0.25, 0.5, 1, 2, 2.5, 3, 3.5, 4 and 5 hours 09/01/2011
1, 9, 16, 17, 18, 19, 45 days 01/03/2007
01/31/2013
10/04/2012
1, 2, 3, 5, 8, 10 and 12 hours 07/21/2009

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