U.S. PHARMACOPEIA

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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.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
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— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 1464
Phone Number : 1-301-816-8223