Sulfinpyrazone Tablets
»Sulfinpyrazone Tablets contain not less than 93.0percent and not more than 107.0percent of the labeled amount of sulfinpyrazone (C23H20N2O3S).
Packaging and storage— Preserve in well-closed containers.
Identification— Finely powder a quantity of Tablets,equivalent to about 400mg of sulfinpyrazone,boil with 20mLof alcohol,and filter.Add water to the filtrate until the solution becomes turbid,allow to stand until crystals form (1to 2hours),remove the crystals by filtration,and dry at 105for 1hour:the sulfinpyrazone so obtained melts between 128and 134,and responds to the Identificationtest under Sulfinpyrazone.
Dissolution á711ñ—
Medium: pH6.8phosphate buffer (see under Buffer Solutionsin the section Reagents,Indicators,and Solutions);900mL.
Apparatus 1: 100rpm.
Time: 45minutes.
Procedure— Determine the amount of C23H20N2O3Sdissolved from UVabsorbances at the wavelength of maximum absorbance at about 259nm of filtered portions of the solution under test,suitably diluted with Dissolution Medium,in comparison with a Standard solution having a known concentration of USP Sulfinpyrazone RSin the same Medium.
Tolerances— Not less than 75%(Q)of the labeled amount of C23H20N2O3Sis dissolved in 45minutes.
Uniformity of dosage units á905ñ: meet the requirements.
Assay—
Acetonitrile and tetrahydrofuran mixture ,Mobile phase,Internal standard solution,Standard preparation,Chromatographic system,and Procedure—Proceed as directed in the Assayfor Sulfinpyrazone Capsules.
Assay preparation— Weigh and finely powder not less than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 100mg of sulfinpyrazone,to a 200-mLvolumetric flask,add 100mLof acetonitrile,mix,add 10.0mLof Internal standard solution,dilute with acetonitrile to volume,and mix.Filter,discarding the first 5mLof the filtrate.
Auxiliary Information— Staff Liaison:Behnam Davani,Ph.D.,MBA,Senior Scientist
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1836
Phone Number:1-301-816-8394