Packaging and storage—
Preserve in tight, light-resistant containers.
Identification—
A:
The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that of the Standard preparation as obtained in the Assay.
B:
A portion of finely powdered Tablets, equivalent to about 20 mg of chlordiazepoxide, responds to
Identification test
C under
Chlordiazepoxide.
Dissolution 
711
—
Medium:
simulated gastric fluid TS, prepared without pepsin; 900 mL.
Apparatus 1:
100 rpm.
Time:
30 minutes.
Procedure—
Determine the amount of C
16H
14ClN
3O dissolved from UV absorbances at the wavelength of maximum absorbance at about 309 nm of filtered portions of the solution under test, suitably diluted with
Dissolution Medium, if necessary, in comparison with a Standard solution having a known concentration of
USP Chlordiazepoxide RS in the same medium.
Tolerances—
Not less than 85% (Q) of the labeled amount of C16H14ClN3O is dissolved in 30 minutes.
Related compounds—
Transfer an accurately weighed portion of finely powdered Tablets, equivalent to about 25 mg of chlordiazepoxide, to a 10-mL conical flask, and proceed as directed in the test for
Related compounds under
Chlordiazepoxide, beginning with “add 2.5 mL of acetone,” except to use 20 µL of an acetone solution containing 1 mg per mL of
USP Chlordiazepoxide Related Compound A RS instead of 10 µL of an acetone solution containing 100 µg per mL of the Reference Standard, and except to use 5 µL of an acetone solution containing 100 µg per mL of
USP 2-Amino-5-chlorobenzophenone RS instead of 10 µL of an acetone solution containing 10 µg per mL of the Reference Standard. Any spots from the test solution are not greater in size or intensity than the spots at the respective
RF values produced by the Standard solutions, corresponding to not more than 4.0% of chlordiazepoxide related compound A, and to not more than 0.1% of 2-amino-5-chlorobenzophenone.
Assay—
Mobile phase
,
Standard preparation, and
Chromatographic system—Proceed as directed in the
Assay under
Chlordiazepoxide.
Assay preparation—
Weigh and finely powder not fewer than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 5 mg of chlordiazepoxide, to a 25-mL volumetric flask, add 20 mL of Mobile phase, sonicate for 5 minutes to dissolve, dilute with Mobile phase to volume, mix, and filter through a 5-µm membrane filter, discarding the first 5 mL of the filtrate.
Procedure—
Proceed as directed for
Procedure in the
Assay under
Chlordiazepoxide. Calculate the quantity, in mg, of C
16H
14ClN
3O in the portion of Tablets taken by the formula:
25C(rU / rS).
