BRIEFING

 Fluticasone Propionate Ointment. This proposal is based on the version of the monograph official prior to 2013. The following changes are proposed:

1. Replace the TLC procedure in Identification A with an identification test based on the UV spectrum agreement of the major peak of the Sample solution and that of the Standard solution, as obtained in the Assay.

2. Revise the Assay as follows:

   • Replace USP Fluticasone Propionate Nasal Spray Resolution Mixture RS with the individual components, USP Fluticasone Propionate RS and USP Fluticasone Propionate Related Compound D RS. Revise the System suitability stock solution and System suitability solution as a result of this replacement. The proposed concentrations of these solutions are consistent with the ratio of USP Fluticasone Propionate RS and USP Fluticasone Propionate Related Compound D RS present in USP Fluticasone Propionate Nasal Spray Resolution Mixture RS.

   • Revise the Sample solution to current USP style and clarify the grade of hexane as n-hexane.

   • Revise the Chromatographic system to include the information for diode array detection needed to support the proposed Identification A.

   • Add a Run time requirement to the Chromatographic system to clarify the instrumental conditions.

   • Add a Note to the System suitability to provide the relative retention times for fluticasone related compound D and fluticasone propionate which are components of the System suitability solution. The typical retention times for fluticasone propionate and fluticasone related compound D are about 7.2 and 8.1 min, respectively.

   • Remove the Tailing factor calculation information since this information is provided under Chromatography 〈621〉, System Suitability.

   • Revise the Relative standard deviation requirement from NMT 2.0% to NMT 1.0% to be consistent with current practices.

3. The references to Microbial Enumeration Tests 〈61〉 and Tests for Specified Microorganisms 〈62〉 are separated to more clearly communicate the requirements associated with each of the general chapters.

4. Remove "protected from light" from the Packaging and Storage requirements to be consistent with the product package inserts.

5. Remove USP Fluticasone Propionate Nasal Spray Resolution Mixture RS and add USP Fluticasone Propionate Related Compound D RS to the USP Reference Standards section to support the proposed revisions.

 The current standard lacks a test and specification for control of degradation products. Manufacturers are encouraged to submit their FDA-approved specifications for the Expert Committee's consideration.

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

 (SM5: H. Ramanathan)

 Case ID—SUB-1155