Nafcillin Sodium for Oral Solution
» Nafcillin Sodium for Oral Solution contains not less than 90.0 percent and not more than 120.0 percent of the labeled amount of nafcillin (C21H22N2O5S). It contains one or more suitable buffers, colors, diluents, dispersants, flavors, and preservatives.
Packaging and storage— Preserve in tight containers.
Uniformity of dosage units 905
for solid packaged in single-unit containers: meets the requirements.
Deliverable volume 698: meets the requirements.
pH 791: between 5.5 and 7.5, in the solution constituted as directed in the labeling.
Water, Method I 921: not more than 5.0%.
Assay— Proceed as directed under Antibiotics—Microbial Assays 81, using Nafcillin Sodium for Oral Solution constituted as directed in the labeling. Dilute an accurately measured volume of the 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
USP32–NF27 Page 3022