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.
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.
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.
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.
1.
Bacterial endotoxins 85—
It contains not more than 3.57 USP Endotoxin Units per mg of chlordiazepoxide hydrochloride.
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).
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.
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 1-301-816-8330 |
(MDPP05) Monograph Development-Psychiatrics and Psychoactives |
| Reference Standards | Lili Wang, Technical Services Scientist 1-301-816-8129 RSTech@usp.org |
|
| 85 |
Radhakrishna S Tirumalai, Ph.D.
Senior Scientist 1-301-816-8339 |
(MSA05) Microbiology and Sterility Assurance |
USP32–NF27 Page 1897