Nafcillin Sodium Capsules
» Nafcillin Sodium Capsules contain not less than 90.0 percent and not more than 120.0 percent of the labeled amount of nafcillin (C21H22N2O5S).
Packaging and storage Preserve in tight containers.
Medium: water; 900 mL.
Apparatus 1: 100 rpm.
Time: 45 minutes.
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 Sodium RS in the same medium.
Tolerances Not less than 75% (Q) of the labeled amount of C21H22N2O5S is dissolved in 45 minutes.
Uniformity of dosage units 905: meet the requirements.
Water, Method I 921: not more than 5.0%.
Assay Proceed as directed under AntibioticsMicrobial Assays 81, using not less than 5 Capsules blended for 4 ± 1 minutes 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. 1 to obtain a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.
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USP32NF27 Page 3021