Chlorpropamide Tablets
»Chlorpropamide Tablets contain not less than 90.0percent and not more than 110.0percent of the labeled amount of C10H13ClN2O3S.
Packaging and storage— Preserve in well-closed containers.
Identification— Shake a quantity of finely powdered Tablets,equivalent to about 100mg of chlorpropamide,with 20mLof 1Nhydrochloric acid,and extract with 50mLof chloroform.Filter the chloroform through chloroform-washed cotton into a suitable beaker,and evaporate the chloroform on a steam bath with the aid of a current of dry air to dryness.Dry the residue at 105for 1hour:the residue so obtained responds to the Identificationtests under Chlorpropamide.
Dissolution á711ñ—
Medium: water;900mL.
Apparatus 2: 50rpm.
Time: 60minutes.
Procedure— Determine the amount of C10H13ClN2O3Sdissolved from UVabsorbances at the wavelength of maximum absorbance at about 230nm of filtered portions of the solution under test,suitably diluted with 0.1Nhydrochloric acid in comparison with a Standard solution having a known concentration of USP Chlorpropamide RSin 0.1Nhydrochloric acid.[NOTE—Avolume of alcohol not exceeding 10%of the final volume of the Standard solution may be used to dissolve the USP Chlorpropamide RS.]
Tolerances— Not less than 75%(Q)of the labeled amount of C10H13ClN2O3Sis dissolved in 60minutes.
Uniformity of dosage units á905ñ: meet the requirements.
Assay—
Mobile phase ,Standard preparation,and Chromatographic system—Proceed as directed in the Assayunder Chlorpropamide.
Assay preparation— Weigh and finely powder not less than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 50mg of chlorpropamide,to a 100-mLvolumetric flask.Add Mobile phaseto volume,mix,and filter,discarding the first 10mLof the filtrate.Pipet 10mLof the filtrate into a second 100-mLvolumetric flask,add Mobile phaseto volume,and mix.
Procedure— Proceed as directed for Procedurein the Assayunder Chlorpropamide.Calculate the quantity,in mg,of C10H13ClN2O3Sin the portion of Tablets taken by the formula:
1000C(rU/rS),
in which Cis the concentration,in mg per mL,of USP Chlorpropamide RSin the Standard preparation,and rUand rSare the peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Elena Gonikberg,Ph.D.,Scientist
Expert Committee:(PA4)Pharmaceutical Analysis 4
USP28–NF23Page 458
Phone Number:1-301-816-8251