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Thiothixene Capsules

The document outlines the specifications and testing methods for Thiothixene Capsules, ensuring they contain between 90.0% and 110.0% of the labeled amount of the active ingredient, C23H29N3O2S2. It details the procedures for preparing standard solutions, conducting assays, and measuring dissolution rates, including specific requirements for equipment and reagents. Additionally, it emphasizes the importance of proper storage and handling to maintain the integrity of the capsules.

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5 views

Thiothixene Capsules

The document outlines the specifications and testing methods for Thiothixene Capsules, ensuring they contain between 90.0% and 110.0% of the labeled amount of the active ingredient, C23H29N3O2S2. It details the procedures for preparing standard solutions, conducting assays, and measuring dissolution rates, including specific requirements for equipment and reagents. Additionally, it emphasizes the importance of proper storage and handling to maintain the integrity of the capsules.

Uploaded by

qa24suresh
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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Printed on: Fri Jan 05 2024, 10:23:08 PM(EST) Status: Currently Official on 06-Jan-2024 DocId: GUID-CBA499C2-F79C-498A-9881-DA330D088459_1_en-US

Printed by: USP NF Official Date: Official Prior to 2013 Document Type: USP @2024 USPC
Do Not Distribute DOI Ref: 1ud99 DOI: https://doi.org/10.31003/USPNF_M83110_01_01
1

discarding the first 5 mL of the filtrate, and diluting the


Thiothixene Capsules subsequent filtrate quantitatively, if necessary, to obtain a
concentration of about 1 µg of thiothixene per mL. Prepare a
» Thiothixene Capsules contain not less than 90.0 Standard preparation of USP Thiothixene RS in Dissolution
Medium having a known concentration of about 1 µg per mL.
percent and not more than 110.0 percent of the Transfer 40.0 mL each of the Test preparation, the Standard
labeled amount of C23H29N3O2S2. preparation, and Dissolution Medium to provide the blank, to
individual separators, each containing 8.0 mL of Buffer
Packaging and storage—Preserve in well-closed, solution, 10.0 mL of Methyl orange solution, and 50.0 mL of
light-resistant containers. chloroform. Shake for 3 minutes, allow the layers to separate,
USP Reference standards á11ñ— transfer 40.0 mL of the chloroform layer, clarified by
USP Thiothixene RS centrifugation, to a 60-mL separator containing 8.0 mL of
Identification—Dissolve a portion of the contents of dilute hydrochloric acid (1 in 120), shake for 1 minute, and
Capsules in a solvent consisting of equal volumes of allow the layers to separate. Concomitantly determine the
chloroform and methanol to obtain a solution containing absorbances of the aqueous layers in 1-cm cells, at the
1 mg of thiothixene per mL. Shake by mechanical means for wavelength of maximum absorbance at about 508 nm, with a
10 minutes, clarify a portion of the mixture by centrifugation, suitable spectrophotometer, using the blank to set the
filter, if necessary, and use the clear supernatant or filtrate for instrument. Calculate the quantity, in µg per mL,
the test. Apply 10 µL of this test solution, 10 µL of a Standard of C23H29N3O2S2 in the Test preparation taken by the formula:
solution containing 1 mg of USP Thiothixene RS per mL in the
same medium, and 10 µL of a mixture of equal volumes of the C(AU/AS)
test solution and the Standard solution to a suitable thin-layer
chromatographic plate (see Chromatography á621ñ) coated in which C is the concentration, in µg per mL, of USP

al
with a 0.25-mm layer of chromatographic silica gel mixture. Thiothixene RS in the Standard preparation, and AU and AS are
Allow the spots to dry, and develop the chromatogram in a the absorbances of the solutions from the Test preparation and
solvent system consisting of a mixture of ethyl acetate, the Standard preparation, respectively, and, from the known
methanol, and diethylamine (65:35:5) until the solvent front extent of dilution, determine the amount of it in the
has moved about three-fourths of the length of the plate. dissolution solution.
Remove the plate from the developing chamber, mark the
solvent front, and locate the spots on the plate by viewing
under short- and long-wavelength UV light. Spray the plate
ci Tolerances—Not less than 80% (Q) of the labeled amount
of C23H29N3O2S2 is dissolved in 20 minutes.
Uniformity of dosage units á905ñ: meet the requirements.
lightly with acidified iodoplatinate spray reagent (prepared by Assay— [NOTE—Perform the dilution operations in low-actinic
mixing 1 volume of hydrochloric acid with 50 volumes of glassware.]
ffi
potassium iodoplatinate TS): the RF value of the principal spot Mobile phase , Standard preparation, and Chromatographic
obtained from the test solution corresponds to that obtained system—Prepare as directed in the Assay under Thiothixene.
from the Standard solution and the mixed test-Standard Assay preparation—Transfer, as completely as possible, the
solution. contents of not less than 20 Capsules to a tared beaker, and
Dissolution á711ñ— weigh. Mix, and transfer an accurately weighed portion of the
powder, equivalent to about 10 mg of thiothixene, to a
O

Medium—Dissolve 2.0 g of sodium chloride and 7 mL of


hydrochloric acid in water to make 1000 mL, and mix; 900 mL. 500-mL volumetric flask. Add about 400 mL of methanol,
Apparatus 1: 100 rpm. shake by mechanical means for 10 minutes, place in an
Time: 20 minutes. ultrasonic bath for 5 minutes, dilute with methanol to volume,
Buffer solution—On the day of use, prepare a mixture of 55 and filter the suspension through a 5-µm polytef membrane
volumes of dibasic potassium phosphate solution (87 in 1000), filter.
20 volumes of citric acid monohydrate solution (21 in 200), Procedure—Proceed as directed for Procedure in the Assay
and 40 volumes of sodium hydroxide solution (1 in 25). under Thiothixene. Calculate the quantity, in mg,
Methyl orange solution—Transfer 15.5 g of boric acid and of C23H29N3O2S2 in the portion of Capsules taken by the
2.0 g of methyl orange to a glass-stoppered, 1000-mL flask. formula:
Add 500 mL of water, insert the stopper, and shake by
mechanical means for not less than 3 hours. Filter through 500C(rU/rS)
retentive filter paper, and wash the filtrate with two 100-mL
portions of chloroform, discarding the chloroform washings. in which C is the concentration, in mg per mL, of USP
Store the Methyl orange solution over 50 mL of chloroform in a Thiothixene RS in the Standard preparation, and rU and rS are
glass-stoppered bottle. the peak responses obtained from the Assay preparation and
Procedure—Prepare a Test preparation by passing a 60-mL the Standard preparation, respectively.
portion of the dissolution solution through a suitable filter,

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