BRIEFING

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

1. Add Identification B based on the UV spectrum agreement utilizing the photo diode array detector from the Assay.

2. In the Assay:

   • Revise the instruction for the handling of the analytical solutions.

   • Revise the Standard solution to remove the related compounds that are not relevant to the Assay.

   • Revise the Detector to support the proposed Identification B.

   • Revise the Column temperature to be consistent with the current chromatographic format.

   • Add "NLT" to clarify the Run time for flexibility.

   • Revise the Suitability requirements to align with current chromatographic expectations.

3. In the test for Organic Impurities:

   • Revise the Standard solution and Sample solution.

   • Add the System suitability solution and Sensitivity solution.

   • Revise the Suitability requirement section by using the proposed Standard solution for the Relative standard deviation requirement and adding the Signal-to-noise ratio requirement using the Sensitivity solution.

   • Add a table and Note in the System suitability section to present relative retention times as an aid in peak assignment.

   • Revise the calculation to quantitate the specified and unspecified degradation products using the respective reference standards to be consistent with FDA's approved application.

   • In the Acceptance criteria, add a reference to User-Determined Reporting Thresholds 〈477〉 for user flexibility.

4. Delete the Tests for Specified Microorganisms 〈62〉 from the title appearing in the Specific Tests section because the currently official text does not include these test procedures.

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

 (SM1: R. Nguyen)

 Case ID—SUB-573