U.S. PHARMACOPEIA

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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.
Dissolution 711—
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 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%.
Residual solvents 467: meet the requirements.
(Official January 1, 2007)
Assay— Proceed as directed under Antibiotics—Microbial 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.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 1469
Phone Number : 1-301-816-8223