Chlordiazepoxide Hydrochloride
C16H14ClN3O·HCl
336.22
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 98.0percent and not more than 102.0percent 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 á11ñ—
USP2-Amino-5-chlorobenzophenone RS.USP Chlordiazepoxide Hydrochloride RS.USP Chlordiazepoxide Related Compound A RS.
Identification—
A:
Infrared Absorption á197Kñ.
B:
The relative retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that of the Standard preparationobtained as directed in the Assay.
C:
To about 20mg add 5mLof hydrochloric acid and 10mLof water,and heat to boiling to effect hydrolysis.To the cooled solution add 2mLof sodium nitrite solution (1in 1000),1mLof ammonium sulfamate solution (1in 200),and 1mLof N-(1-naphthyl)ethylenediamine dihydrochloride solution (1in 1000):a reddish violet color is produced.
Loss on drying á731ñ—
Dry it in vacuum over phosphorus pentoxide at 60
for 4hours:it loses not more than 0.5%of its weight.
for 4hours:it loses not more than 0.5%of its weight.
Residue on ignition á281ñ:
not more than 0.1%.
Heavy metals,Method IIá231ñ:
0.002%.
Related compounds—
It meets the requirements of the test for Related compoundsunder Chlordiazepoxide.
Organic volatile impurities,Method IVá467ñ:
meets the requirements.
Standard solution—
Prepare a solution in 0.001Nhydrochloric acid containing in each mL1.0µg of chloroform and 2.0µg each of benzene,1,4-dioxane,methylene chloride,and trichloroethylene.Pipet 5mLof the solution into a vial fitted with a septum and crimp cap,and seal.Heat the sealed vial at 80for 15minutes.
for 15minutes.
Test solution—
Dissolve in 0.001Nhydrochloric acid an accurately weighed portion of Chlordiazepoxide Hydrochloride to obtain a final solution having a known concentration of about 20mg per mL.Pipet 5mLof the solution into a vial fitted with a septum and crimp cap,and seal.Heat the sealed vial at 80for 15minutes.
for 15minutes.
Other requirements—
Where the label states that Chlordiazepoxide Hydrochloride is sterile,it meets the requirements for Sterility Tests á71ñand Labelingunder Injections á1ñ,and Bacterial endotoxinsunder 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 endotoxinsunder Chlordiazepoxide Hydrochloride for Injection.
Assay—
[NOTE—Use low-actinic glassware in this procedure.]Proceed as directed in the Assayunder Chlordiazepoxide,except to use USP Chlordiazepoxide Hydrochloride RSwhen preparing the Standard preparation.
Auxiliary Information—
Staff Liaison:Ravi Ravichandran,Ph.D.,Senior Scientist
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 437
Pharmacopeial Forum:Volume No.29(6)Page 1859
Phone Number:1-301-816-8330