Chlordiazepoxide Hydrochloride for Injection
» Chlordiazepoxide Hydrochloride for Injection is Chlordiazepoxide Hydrochloride suitable for parenteral use.
Packaging and storage— Preserve in Containers for Sterile Solids as described under Injections 1, protected from light.
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).
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 Hydrochloride RS to prepare the Standard preparation.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ravi Ravichandran, Ph.D.
Senior Scientist
(MDPP05) Monograph Development-Psychiatrics and Psychoactives
Reference Standards Lili Wang, Technical Services Scientist
85 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 1897