Sulfisoxazole Tablets
»Sulfisoxazole Tablets contain not less than 95.0percent and not more than 105.0percent of the labeled amount of C11H13N3O3S.
Packaging and storage— Preserve in well-closed,light-resistant containers.
Identification— Extract a quantity of powdered Tablets,equivalent to about 1g of sulfisoxazole,with 50mLof alcohol by boiling on a steam bath for 3minutes,then immediately filter into a beaker.Allow to stand until a quantity of fine,needle-like crystals form.Cool,filter off the crystals,recrystallize from a small volume of alcohol,and dry at 105:the crystals respond to Identificationtest Aunder Sulfisoxazole.
Dissolution á711ñ—
Medium: dilute hydrochloric acid (1in 12.5);900mL.
Apparatus 1: 100rpm.
Time: 30minutes.
Procedure— [NOTE—Because of the pH-dependent nature of the UVabsorption spectrum,prepare the standard and specimen solutions in the same strength of acid at approximately equal concentrations.]Determine the amount of C11H13N3O3Sdissolved from UVabsorbances at the wavelength of maximum absorbance at about 267nm of filtered portions of the solution under test,suitably diluted with water,if necessary,in comparison with a Standard solution having a known concentration of USP Sulfisoxazole RSin the same medium.
Tolerances— Not less than 70%(Q)of the labeled amount of C11H13N3O3Sis dissolved in 30minutes.
Uniformity of dosage units á905ñ: meet the requirements.
Assay— Weigh and finely powder not less than 20Tablets.Weigh accurately a portion of the powder,equivalent to about 800mg of sulfisoxazole,transfer to a 250-mLconical flask,and proceed as directed in the Assayunder Sulfisoxazole,beginning with “add 50mLof dimethylformamide.”
Auxiliary Information— Staff Liaison:Behnam Davani,Ph.D.,MBA,Senior Scientist
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1837
Phone Number:1-301-816-8394