BRIEFING

 Ciclopirox Olamine Cream. This proposal is based on the version of the monograph official prior to 2013. It is proposed to revise the monograph as follows:

1. Revise the title of the current USP monograph Ciclopirox Olamine Cream to Ciclopirox Cream based on USP's Nomenclature Expert Committee's decision. Accordingly, the Definition section is updated to reflect the revised title.

2. Replace the identification procedure with Identification A, which is based on the UV spectrum agreement utilizing the photo diode array detector from the proposed Assay.

3. Add Identification B based on the retention time agreement from the proposed Assay.

4. Replace the spectrometric Assay with a validated LC procedure. The proposed LC procedure was validated using the Zorbax SB-CN brand of column with L10 packing. The typical retention time for ciclopirox is about 10 min.

5. Replace the packed column gas chromatography procedure for the Content of Benzyl Alcohol test with a capillary column gas chromatography procedure. The proposed GC procedure was validated using the DB-Wax fused silica brand of column coated with G16 phase. The typical retention time for benzyl alcohol is about 4 min.

6. Add an Organic Impurities test based on a validated LC procedure. The proposed LC procedure was validated using the Zorbax SB-CN brand of column with L10 packing. The typical retention time for ciclopirox is about 11 min.

7. Add microbial tests to align with FDA-approved applications.

8. Add USP Ciclopirox Related Compound B RS, USP Ciclopirox Related Compound C RS, and USP Phenol RS to the USP Reference Standards section to support the proposed revisions.

 Additionally, minor editorial changes have been made to update the monograph to current USP style.

 (SM1: R. Nguyen)

 Case ID—SUB-571