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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.
Dissolution á711ñ—
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.
Medium:
pH4.0buffer;900mL.
Apparatus 2:
50rpm.
Time:
45minutes.
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 Antibiotics—Microbial 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
USP28–NF23Page 1324
Phone Number:1-301-816-8335
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