BRIEFING

 Miconazole Nitrate Vaginal Suppositories. This proposal is based on the version of the monograph official prior to 2013. It is proposed to revise the monograph with the following changes:

1. Add reference to Spectroscopic Identification Test 〈197〉, Infrared Spectroscopy: 197K in Identification A.

2. Add Identification B based on the chromatographic retention time agreement in the proposed Assay.

3. Replace the gas chromatography procedure and the packed column in the Assay with an HPLC procedure. The chromatographic procedure was validated using the Kinetex Phenyl-Hexyl brand of column with L11 packing. The typical retention time for miconazole is about 24 min.

4. Add an Organic Impurities test with the same Mobile phase and chromatographic conditions as those in the proposed HPLC assay procedure. The reporting thresholds and unspecified degradation products are based on the User-Determined Reporting Thresholds 〈477〉 and ICH guidelines Q3B (R2), respectively. The acceptance criterion for total degradation products is proposed at 0.5%. Stakeholders are encouraged to submit FDA-approved specifications for the Expert Committee's consideration.

5. Add USP Miconazole Related Compound F RS to the USP Reference Standards section to support the proposed Organic Impurities test.

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

 (SM1: A. Adekoya)

 Case ID—SUB-2542