3
H-1,4-Benzodiazepin-2-amine, 7-chloro-
N-methyl-5-phenyl-, 4-oxide, monohydrochloride.
7-Chloro-2-(methylamino)-5-phenyl-3
H-1,4-benzodiazepine 4-oxide monohydrochloride
[
438-41-5].
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.
Identification—
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.
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.
Heavy metals, Method II 231:
0.002%.
Related compounds—
It meets the requirements of the test for Related compounds under Chlordiazepoxide.
Organic volatile impurities, Method IV 467:
meets the requirements.
Standard solution—
Prepare a solution in 0.001 N hydrochloric acid containing in each mL 1.0 µg of chloroform and 2.0 µg each of benzene, 1,4-dioxane, methylene chloride, and trichloroethylene. Pipet 5 mL of the solution into a vial fitted with a septum and crimp cap, and seal. Heat the sealed vial at 80
for 15 minutes.
Test solution—
Dissolve in 0.001 N hydrochloric acid an accurately weighed portion of Chlordiazepoxide Hydrochloride to obtain a final solution having a known concentration of about 20 mg per mL. Pipet 5 mL of the solution into a vial fitted with a septum and crimp cap, and seal. Heat the sealed vial at 80
for 15 minutes.
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—
[NOTE—Use 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—
Staff Liaison :
Ravi Ravichandran, Ph.D., Senior Scientist
Expert Committee : (MDPP05) Monograph Development-Psychiatrics and Psychoactives
USP29–NF24 Page 473
Pharmacopeial Forum : Volume No. 29(6) Page 1859
Phone Number : 1-301-816-8330
