Chlordiazepoxide Tablets
» Chlordiazepoxide Tablets contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C16H14ClN3O.
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 C16H14ClN3O 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.
Uniformity of dosage units 905: meet the requirements.
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 C16H14ClN3O in the portion of Tablets taken by the formula:
25C(rU / rS).
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
711 Margareth R.C. Marques, Ph.D.
Senior Scientist
1-301-816-8106		 (BPC05) Biopharmaceutics05
USP32–NF27 Page 1894
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.