BRIEFING

 Sorbitan Monopalmitate. 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 Melting Range or Temperature, 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 method in the test for Analysis of Sorbitan Triesters and/or Higher Order Esters, 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 triesters and/or higher order esters, sorbitan diesters, sorbitan monoesters, and isosorbide monoesters peaks with respect to the isosorbide peak are about 0.74, 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 palmitic acid) and 1,4-sorbitan with respect to the isosorbide peak are about 0.87 and 0.92, respectively.

6. In the Specific Tests section, add the test for Fatty Acid Composition, as per Fats and Fixed Oils 〈401〉 along with the test for Melting Range or Temperature.

7. Add USP Palmitic 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-689