Chlordiazepoxide Tablets
»Chlordiazepoxide Tablets contain not less than 90.0percent and not more than 110.0percent 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 preparationcorresponds to that of the Standard preparationas obtained in the Assay.
B: Aportion of finely powdered Tablets,equivalent to about 20mg of chlordiazepoxide,responds to Identificationtest Cunder Chlordiazepoxide.
Dissolution á711ñ—
Medium: simulated gastric fluid TS,prepared without pepsin;900mL.
Apparatus 1: 100rpm.
Time: 30minutes.
Procedure— Determine the amount of C16H14ClN3Odissolved from UVabsorbances at the wavelength of maximum absorbance at about 309nm 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 RSin the same medium.
Tolerances— Not less than 85%(Q)of the labeled amount of C16H14ClN3Ois dissolved in 30minutes.
Uniformity of dosage units á905ñ: meet the requirements.
Related compounds— Transfer an accurately weighed portion of finely powdered Tablets,equivalent to about 25mg of chlordiazepoxide,to a 10-mLconical flask,and proceed as directed in the test for Related compoundsunder Chlordiazepoxide,beginning with “add 2.5mLof acetone,”except to use 20µLof an acetone solution containing 1mg per mLof USP Chlordiazepoxide Related Compound A RSinstead of 10µLof an acetone solution containing 100µg per mLof the Reference Standard,and except to use 5µLof an acetone solution containing 100µg per mLof USP2-Amino-5-chlorobenzophenone RSinstead of 10µLof an acetone solution containing 10µg per mLof the Reference Standard.Any spots from the test solution are not greater in size or intensity than the spots at the respective RFvalues 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 Assayunder Chlordiazepoxide.
Assay preparation— Weigh and finely powder not less than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 5mg of chlordiazepoxide,to a 25-mLvolumetric flask,add 20mLof Mobile phase,sonicate for 5minutes to dissolve,dilute with Mobile phaseto volume,mix,and filter through a 5-µm membrane filter,discarding the first 5mLof the filtrate.
Procedure— Proceed as directed for Procedurein the Assayunder Chlordiazepoxide.Calculate the quantity,in mg,of C16H14ClN3Oin the portion of Tablets taken by the formula:
25C(RU/RS).
Auxiliary Information— Staff Liaison:Ravi Ravichandran,Ph.D.,Senior Scientist
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 436
Phone Number:1-301-816-8330