Nafcillin Sodium Tablets
»Nafcillin Sodium Tablets contain not less than 90.0percent and not more than 120.0percent of the labeled amount of nafcillin (C21H22N2O5S).
Packaging and storage Preserve in tight,light-resistant containers.
pH4.0buffer Transfer 10.94g of anhydrous dibasic sodium phosphate and 12.92g of citric acid monohydrate to a 1-liter volumetric flask,dissolve in water,dilute with water to volume,and mix.
Apparatus 2: 50rpm.
Procedure Determine the amount of nafcillin (C21H22N2O5S)dissolved from UVabsorbances,at the wavelength of maximum absorbance at about 280nm of filtered portions of the solution under test,suitably diluted with Medium,if necessary,in comparison with a Standard solution having a known concentration of USP Nafcillin Sodium RSin the same medium.
Tolerances Not less than 75%(Q)of the labeled amount of nafcillin (C21H22N2O5S)is dissolved in 45minutes.
Uniformity of dosage units á905ñ: meet the requirements.
Water,Method Iá921ñ: not more than 5.0%.
Assay Proceed as directed under AntibioticsMicrobial Assays á81ñ,using not less than 5Tablets blended for 4±1minutes in a high-speed glass blender jar containing an accurately measured volume of Buffer No.1.Dilute an accurately measured volume of this stock solution quantitatively with Buffer No.1to obtain a Test Dilutionhaving a concentration assumed to be equal to the median dose level of the Standard.
Auxiliary Information Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7