BRIEFING

 Sorbitan Trioleate. This proposal is based on the version of the monograph official as of January 1, 2018. On the basis of comments and data received and based on the validated methods of analysis, it is proposed to make the following revisions:

1. Revise the Definition in accordance with the newly added Assay.

2. Replace the current Identification A and Identification B procedures with the Specific Tests for Hydroxyl Value and Iodine Value, respectively.

3. Add an Identification C test based on the procedure in Fats and Fixed Oils, Fatty Acid Composition.

4. In the Assay, replace the current tests for Fatty Acids and Polyols with a gel permeation chromatography (GPC) based procedure. The GPC procedure in the test for Analysis of Sorbitan Higher Order Esters, Sorbitan Triesters, Sorbitan Diesters, Sorbitan Monoesters, and Isosorbide Monoesters is based on analyses performed with the Styragel HR 0.5 and HR 1 brand of columns in series with L21 packing. The typical relative retention times for the sorbitan higher order esters, sorbitan triesters, sorbitan diesters, sorbitan monoesters, and isosorbide monoesters peaks with respect to the isosorbide peak are about 0.72, 0.73, 0.76, 0.81, and 0.84, respectively.

5. In the Impurities section, add the Organic Impurities test. The test utilizes similar chromatographic conditions as those of the Assay. The typical relative retention times for fatty acid (as oleic acid) and 1,4-sorbitan with respect to the isosorbide peak are about 0.86 and 0.92, respectively.

6. In the Specific Tests section, add the procedure for Fatty Acid Composition by constituent oleic acid, using the test in Fats and Fixed Oils, Fatty Acid Composition.

7. Add USP Oleic Acid RS to the USP Reference Standards section.

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

 (CE: D. Chavan)

 Case ID—SUB-690