Dissolution Methods
Dissolution Methods
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)
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
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
Risperidone Injectable
Verteporfin Injectable
Granisetron Injectable (Extended
Release)
Leuprolide Acetate Injectable (Extended
Release)
I (Suppository, dissolution
Prochlorperazine Rectal Suppository
baskets, palmieri type)
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)
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)
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
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)
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
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 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
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
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
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
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
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
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
07/02/2020
07/02/2020
15, 20, 30, 45, 60 and 75 08/19/2021
08/15/2013
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
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
03/17/2016
02/28/2013
02/28/2013
1, 2, 3, 5, 7 and 10 10/31/2013
10/28/2010
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
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
02/08/2018
01/15/2010
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
07/02/2020
10, 15, 20, 30 and 45 06/07/2012
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
11/02/2017
07/02/2020
5, 10, 15, 20, 30 and 45 05/12/2022
07/02/2020
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
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
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
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
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
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
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
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
04/22/2021
02/07/2019
1, 4, 8, 12 hours 10/06/2008
1, 4, 8, 12 hours 10/06/2008
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
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
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
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
1, 4, 24 hours 01/03/2007