Mupirocin Ointment, chemical structure, molecular formula, Reference Standards

Mupirocin Ointment

»Mupirocin Ointment contains not less than 90.0percent and not more than 110.0percent of the labeled amount of mupirocin (C26H44O9).

Packaging and storage— Preserve in collapsible tubes or in well-closed containers.

USP Reference standards á11ñ— USP Mupirocin Lithium RS.

Identification— The chromatogram of the Assay preparationobtained as directed in the Assayexhibits a major peak for mupirocin,the retention time of which corresponds to that exhibited in the chromatogram of the Standard preparationobtained as directed in the Assay.

Minimum fill á755ñ: meets the requirements.

Assay—

pH6.3phosphate buffer,Mobile phase,Standard preparation,Resolution solution,and Chromatographic system— Proceed as directed in the Assayunder Mupirocin.

Assay preparation— Dissolve an accurately weighed quantity of Ointment,equivalent to about 10mg of mupirocin,in 25mLof acetonitrile.Transfer this solution,with the aid of pH6.3phosphate buffer,to a 100-mLvolumetric flask,dilute with pH6.3phosphate bufferto volume,and mix.

Procedure— Proceed as directed for Procedurein the Assayunder Mupirocin.Calculate the quantity,in mg,of mupirocin (C26H44O9)in the portion of Ointment taken by the formula:

(MSE/1000)(rU/rS),

in which the terms are as defined therein.

Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow

Expert Committee:(PA7)Pharmaceutical Analysis 7

USP28–NF23Page 1318

Phone Number:1-301-816-8335