Ciclopirox Olamine Topical Suspension, chemical structure, molecular formula, Reference Standards

Ciclopirox Olamine Topical Suspension

»Ciclopirox Olamine Topical Suspension contains not less than 90.0percent and not more than 110.0percent of the labeled amount of C12H17NO2·C2H7NO.

Packaging and storage— Preserve in tight containers.

USP Reference standards á11ñ— USP Ciclopirox Olamine RS.

Identification— It responds to the Identificationtest under Ciclopirox Olamine Cream.

Minimum fill á755ñ: meets the requirements.

pHá791ñ— Proceed as directed for pHunder Ciclopirox Olamine Cream,except to read “Topical Suspension”in place of “Cream”throughout.

Benzyl alcohol content— Proceed as directed for Benzyl alcohol contentunder Ciclopirox Olamine Cream,except to read “Topical Suspension”in place of “Cream”throughout.

Assay— Proceed as directed in the Assayunder Ciclopirox Olamine Cream,except to read “Topical Suspension”in place of “Cream”throughout.

Auxiliary Information— Staff Liaison:Behnam Davani,Ph.D.,MBA,Senior Scientist

Expert Committee:(PA7)Pharmaceutical Analysis 7

USP28–NF23Page 471

Pharmacopeial Forum:Volume No.30(5)Page 1596

Phone Number:1-301-816-8394