Chlordiazepoxide Hydrochloride Capsules
»Chlordiazepoxide Hydrochloride Capsules contain not less than 90.0percent and not more than 110.0percent of the labeled amount of C16H14ClN3O·HCl.
Packaging and storage— Preserve in tight,light-resistant containers.
Identification—
A: The solution employed for measurement of absorbance in the Assayexhibits maxima at 245±2nm and 311±2nm,and the ratio A245/A311is between 2.90and 3.45.
B: Aportion of the contents of Capsules responds to Identificationtest Cunder Chlordiazepoxide Hydrochloride.
Dissolution á711ñ
Medium: water;900mL.
Apparatus 1: 100rpm.
Time: 30minutes.
Procedure— Measure the amount in solution in filtered portions of the Dissolution Medium,suitably diluted,in 1-cm cells at the wavelength of maximum absorbance at about 245nm,with a suitable spectrophotometer,in comparison with a Standard solution of known concentration of USP Chlordiazepoxide Hydrochloride RS.Remove the contents of 12Capsules as completely as possible with the aid of a current of air.Dissolve the empty capsule shells in 900mLof Dissolution Medium.Filter a portion of the solution,and determine the absorbance at the same dilution and in the same manner as for the Capsules,making any necessary modifications.
Tolerances— Not less than 85%(Q)of the labeled amount of C16H14ClN3O·HCl is dissolved in 30minutes.
Uniformity of dosage units á905ñ: meet the requirements.
Procedure for content uniformity— [NOTE—Use low-actinic glassware in this procedure.]Transfer the contents of 1Capsule to a 200-mLvolumetric flask,dissolve in and dilute with water to volume,and filter,discarding the first 20mLof the filtrate.Dilute a portion of the filtrate quantitatively and stepwise with 0.1Nhydrochloric acid to obtain a solution having a concentration of about 6µg of chlordiazepoxide hydrochloride per mL.Dissolve a suitable quantity of USP Chlordiazepoxide Hydrochloride RS,accurately weighed,in 0.1Nhydrochloric acid to obtain a Standard solution having a known concentration of about 6µg per mL.Concomitantly determine the absorbances of the two solutions in 1-cm cells at the wavelength of maximum absorbance at about 245nm,with a suitable spectrophotometer,using 0.1Nhydrochloric acid as the blank.Calculate the quantity,in mg,of C16H14ClN3O·HCl in the Capsule by the formula:
(T/D)C(AU/AS),
in which Tis the labeled quantity,in mg,of chlordiazepoxide hydrochloride in the Capsule,Dis the concentration,in µg per mL,of chlordiazepoxide hydrochloride in the test solution,based on the labeled quantity per Capsule and the extent of dilution,Cis the concentration,in µg per mL,of USP Chlordiazepoxide Hydrochloride RSin the Standard solution,and AUand ASare the absorbances of the solution from the contents of the Capsule and the Standard solution,respectively.
Related compounds— Proceed as directed for Related compoundsunder Chlordiazepoxide Hydrochloride,but use an accurately weighed portion of Capsule contents,equivalent to about 25mg of chlordiazepoxide hydrochloride,and use 15µLof a 1in 1000solution of USP Chlordiazepoxide Related Compound A RSin acetone and 10µLof a 1in 20,000solution of USP2-Amino-5-chlorobenzophenone RSin acetone.Not more than 3.0%of chlordiazepoxide related compound Ais found,and not more than 0.1%of 2-amino-5-chlorobenzophenone is found.
Assay— [NOTE—Use low-actinic glassware in this procedure.]Proceed as directed in the Assayunder Chlordiazepoxide Tabletsexcept to use an accurately weighed portion of capsule contents equivalent to about 5mg of chlordiazepoxide hydrochloride and USP Chlordiazepoxide Hydrochloride RSin preparing the Standard preparation.
Auxiliary Information— Staff Liaison:Ravi Ravichandran,Ph.D.,Senior Scientist
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 437
Phone Number:1-301-816-8330