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Nafcillin Sodium Capsules
»Nafcillin Sodium Capsules 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 containers.
Dissolution á711ñ—
Medium:
water;900mL.
Apparatus 1:
100rpm.
Time:
45minutes.
Procedure—
Determine the amount of nafcillin (C21H22N2O5S)by a suitable validated spectrophotometric analysis of a filtered portion of the solution under test,suitably diluted with Medium,if necessary,in comparison with a Standard solution having a known concentration of USP Nafcillin RSin the same medium.
Tolerances—
Not less than 75%(Q)of the labeled amount of C21H22N2O5Sis 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 5Capsules 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 1323
Phone Number:1-301-816-8335
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