Mupirocin Ointment
» Mupirocin Ointment contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of mupirocin (C26H44O9).
Packaging and storage— Preserve in collapsible tubes or in well-closed containers.
Identification— The chromatogram of the Assay preparation obtained as directed in the Assay exhibits a major peak for mupirocin, the retention time of which corresponds to that exhibited in the chromatogram of the Standard preparation obtained as directed in the Assay.
Minimum fill 755: meets the requirements.
Assay—
pH 6.3 phosphate buffer, Mobile phase, Standard preparation, Resolution solution, and Chromatographic system— Proceed as directed in the Assay under Mupirocin.
Assay preparation— Dissolve an accurately weighed quantity of Ointment, equivalent to about 10 mg of mupirocin, in 25 mL of acetonitrile. Transfer this solution, with the aid of pH 6.3 phosphate buffer, to a 100-mL volumetric flask, dilute with pH 6.3 phosphate buffer to volume, and mix.
Procedure— Proceed as directed for Procedure in the Assay under Mupirocin. Calculate the quantity, in mg, of mupirocin (C26H44O9) in the portion of Ointment taken by the formula:
(MS E / 1000)(rU / rS)
in which the terms are as defined therein.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ahalya Wise, M.S.
Scientist
1-301-816-8161		 (MDANT05) Monograph Development-Antibiotics
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
USP32–NF27 Page 3015
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.