Packaging and storage— Preserve in Containers for Sterile Solids as described under Injections 1, protected from light.

USP Reference standards 11— USP 2-Amino-5-chlorobenzophenone RS. USP Endotoxin RS. USP Chlordiazepoxide Hydrochloride RS. USP Chlordiazepoxide Related Compound A RS.

Completeness of solution 641— It dissolves in the solvent and in the concentration recommended in the labeling to yield a clear solution.

Constituted solution— At the time of use, it meets the requirements for Constituted Solutions under Labeling under Injections 1.

Bacterial endotoxins 85— It contains not more than 3.57 USP Endotoxin Units per mg of chlordiazepoxide hydrochloride.

pH 791: between 2.5 and 3.5, in a solution (1 in 100).

Residual solvents 467: meets the requirements.

Other requirements— It responds to the Identification tests and meets the requirements of the tests for Loss on drying and Heavy metals under Chlordiazepoxide Hydrochloride, and the test for Related compounds under Chlordiazepoxide. It meets also the requirements for Sterility Tests 71, Uniformity of Dosage Units 905, and Labeling under Injections 1.

Assay— Proceed with Chlordiazepoxide Hydrochloride for Injection as directed in the Assay under Chlordiazepoxide , except to use USP Chlordiazepoxide RS to prepare the Standard preparation.

Expert Committee : (MDPP05) Monograph Development-Psychiatrics and Psychoactives

USP29–NF24 Page 474

Phone Number : 1-301-816-8330