BRIEFING

 Ethyl Oleate. This proposal is based on the version of the monograph official as of August 1, 2016. To modernize the existing standard from qualitative use of reference standards to quantitative use, and based on the data received, it is proposed to make the following changes:

1. Revise the GC-FID method in the Assay, which has been re-validated using a 0.25-mm × 25-m Agilent CP-Wax 52 CB brand of capillary column bonded with a 0.2-µm layer of phase G16 to propose weight by weight calculation replacing the existing area normalization calculation. The relative retention times for the ethyl palmitate, ethyl stearate, ethyl oleate, and ethyl linoleate peaks from the System suitability solution are about 0.66, 0.96, 1.00, and 1.08, respectively.

2. In the Assay, revise the Sample solution concentration from 5.0 mg/mL to 0.5 mg/mL.

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

 (EXC1: R. Challa)

 Case ID—SUB-2291