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 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.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ahalya Wise, M.S.
(MDANT05) Monograph Development-Antibiotics
Reference Standards Lili Wang, Technical Services Scientist
711 Margareth R.C. Marques, Ph.D.
Senior Scientist
(BPC05) Biopharmaceutics05
USP32–NF27 Page 3021