BRIEFING

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

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 Fats and Fixed Oils, Fatty Acid Composition, respectively.

3. In the Assay, replace the current tests for Fatty Acids and Polyols with a gel permeation chromatography (GPC)-based procedure. The GPC method is performed by using two Waters Styragel 7.8-mm × 30-cm, 5-µm, HR 0.5 columns and one Waters Styragel 7.8-mm × 30-cm, 5-µm, HR 1.0 column with L21 packing connected in series. The typical relative retention times for the sum of sorbitan triesters and sorbitan diesters, sorbitan monoesters, and isosorbide monoesters with respect to the isosorbide peak are 0.78, 0.82, and 0.87, respectively.

4. In the Impurities section, add the Limit of Organic Impurities test. The test utilizes similar chromatographic conditions as those of the Assay. The typical relative retention times for the fatty acid (as lauric acid) and 1,4-sorbitan with respect to the isosorbide peak are 0.89 and 0.92, respectively.

5. In the Specific Tests section, add the test for Fats and Fixed Oils, Fatty Acid Composition.

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

 (CE: V. Grandhi)

 Case ID—SUB-692