(klor'' dye az'' e pox' ide hye'' droe klor' ide).
3H-1,4-Benzodiazepin-2-amine, 7-chloro-N-methyl-5-phenyl-, 4-oxide, monohydrochloride.
7-Chloro-2-(methylamino)-5-phenyl-3H-1,4-benzodiazepine 4-oxide monohydrochloride [438-41-5].
» Chlordiazepoxide Hydrochloride contains not less than 98.0 percent and not more than 102.0 percent of C16H14ClN3O·HCl, calculated on the dried basis.
Packaging and storage Preserve in tight, light-resistant containers.
Labeling Where it is intended for use in preparing injectable dosage forms, the label states that it is sterile or must be subjected to further processing during the preparation of injectable dosage forms.
USP Reference standards 11
USP Chlordiazepoxide Related Compound A RS
USP Endotoxin RS
B: The relative retention time of the major peak in the chromatogram of the Assay preparation corresponds to that of the Standard preparation obtained as directed in the Assay.
C: To about 20 mg add 5 mL of hydrochloric acid and 10 mL of water, and heat to boiling to effect hydrolysis. To the cooled solution add 2 mL of sodium nitrite solution (1 in 1000), 1 mL of ammonium sulfamate solution (1 in 200), and 1 mL of N-(1-naphthyl)ethylenediamine dihydrochloride solution (1 in 1000): a reddish violet color is produced.
Melting range, Class I 741: between 212 and 218, with decomposition.
Loss on drying 731 Dry it in vacuum over phosphorus pentoxide at 60 for 4 hours: it loses not more than 0.5% of its weight.
Residue on ignition 281: not more than 0.1%.
Heavy metals, Method II 231: 0.002%.
Related compounds It meets the requirements of the test for Related compounds under Chlordiazepoxide.
Other requirements Where the label states that Chlordiazepoxide Hydrochloride is sterile, it meets the requirements for Sterility Tests 71 and Labeling under Injections 1, and Bacterial endotoxins under Chlordiazepoxide Hydrochloride for Injection. Where the label states that Chlordiazepoxide Hydrochloride must be subjected to further processing during the preparation of injectable dosage forms, it meets the requirements for Bacterial endotoxins under Chlordiazepoxide Hydrochloride for Injection.
Assay [noteUse low-actinic glassware in this procedure. ] Proceed as directed in the Assay under Chlordiazepoxide, except to use USP Chlordiazepoxide Hydrochloride RS when preparing the Standard preparation.
Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 2618Pharmacopeial Forum: Volume No. 29(6) Page 1859