Chlordiazepoxide Hydrochloride Capsules

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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1 DEFINITION

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Chlordiazepoxide Hydrochloride Capsules contain NLT 90.0% and NMT 110.0% of the labeled amount of chlordiazepoxide hydrochloride (C₁₆H₁₄ClN₃O · HCl).

Protect all solutions containing chlordiazepoxide from light. (USP 1-Dec-2022)

2 IDENTIFICATION

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A. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay. (USP 1-Dec-2022)

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B. The UV spectrum of the chlordiazepoxide peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay. (USP 1-Dec-2022)

3 ASSAY

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PROCEDURE

Solution A: 0.63 g/L of ammonium formate prepared as follows. Dissolve 2.52 g of ammonium formate in 4 L of water. Adjust with 98% formic acid to a pH of 3.0.

Solution B: Acetonitrile

Solution C: 0.1 N hydrochloric acid solution prepared as follows. To a 1-L volumetric flask containing about 400 mL of water, add 8.3 mL of hydrochloric acid and dilute with water to volume.

Solution D: Acetonitrile and Solution C (50:50)

Solution E: Transfer 12.0 mL of 10 N sodium hy droxide TS to a 100-mL volumetric flask containing about 40 mL of water. Dilute with water to volume.

Mobile phase: See Table 1.