Nafcillin Sodium Tablets
» Nafcillin Sodium Tablets 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, light-resistant containers.
Dissolution 711
pH 4.0 buffer— Transfer 10.94 g of anhydrous dibasic sodium phosphate and 12.92 g of citric acid monohydrate to a 1-liter volumetric flask, dissolve in water, dilute with water to volume, and mix.
Medium: pH 4.0 buffer; 900 mL.
Apparatus 2: 50 rpm.
Time: 45 minutes.
Procedure— Determine the amount of nafcillin (C21H22N2O5S) dissolved from UV absorbances, at the wavelength of maximum absorbance at about 280 nm 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 RS in the same medium.
Tolerances— Not less than 75% (Q) of the labeled amount of nafcillin (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 Antibiotics—Microbial Assays 81, using not less than 5 Tablets 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 3023