BRIEFING

 Oleyl Oleate. This proposal is based on the version of the monograph official as of May 1, 2020. As part of the USP monograph modernization effort and on the basis of public comments received, the earlier version of this proposal which appeared in PF 47(1) [Jan.–Feb. 2021] has been canceled, and revised with the current proposal. It is proposed to make the following changes:

1. In the Definition, update the source and origin of oleic acid, and add an Acceptance criteria of 55.0%–90.0% for Oleyl Oleate 70.

2. In the Identification section, add a test for Chromatographic Identification.

3. Add an Assay procedure with a GC method of analysis performed using the Agilent DB-1 brand of column with G2 phase. The relative retention times for oleyl oleate and oleyl stearate are about 1.00 and 1.02, respectively.

4. Update the Impurities section to remove the Arsenic test.

5. Update the storage requirements in the Packaging and Storage section.

6. Add a Labeling requirement that will help the user select the appropriate excipient.

7. Update the USP Reference Standards section to delete USP Oleyl Oleate RS and add USP Oleyl Oleate 95 RS and USP Oleyl Stearate RS.

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

 (CE: R. Challa)

 Case ID—SUB-560