Packaging and storage— Preserve in Containers for Sterile Solidsas described under Injections á1ñ,protected from light.

USP Reference standards á11ñ— USP2-Amino-5-chlorobenzophenone RS.USP Endotoxin RS.USP Chlordiazepoxide Hydrochloride RS.USP Chlordiazepoxide Related Compound A RS.

Completeness of solution á641ñ— 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 Solutionsunder Labelingunder Injections á1ñ.

Bacterial endotoxins á85ñ— It contains not more than 3.57USP Endotoxin Units per mg of chlordiazepoxide hydrochloride.

pHá791ñ: between 2.5and 3.5,in a solution (1in 100).

Other requirements— It responds to the Identificationtests and meets the requirements of the tests for Loss on dryingand Heavy metalsunder Chlordiazepoxide Hydrochloride,and the test for Related compoundsunder Chlordiazepoxide.It meets also the requirements for Sterility Tests á71ñ,Uniformity of Dosage Units á905ñ,and Labelingunder Injections á1ñ.

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

Expert Committee:(PA3)Pharmaceutical Analysis 3

USP28–NF23Page 438

Phone Number:1-301-816-8330