BRIEFING

 Glyceryl Dibehenate. This proposal is based on the version of the monograph official as of January 1, 2018. On the basis of comments received from external stakeholders on the usage of pyridine as a solvent for water determination, as well as on validation data provided, the following revisions to the monograph are being proposed:

1. Add CAS no. 77538-19-3 in the Chemical Information section.

2. Add a specific instruction to the Assay to integrate the monoglyceride peak with the adjacent shoulder peak corresponding to free fatty acids when subtracting the free fatty acid content value to determine the accurate content of monoglycerides.

3. Revise the System suitability solution and Sample solution preparations in the Assay and the Sample solution preparation in the Limit of Free Glycerin test to remove the specified temperature.

4. Replace Method 1a with Method Ic in the Water Determination test to use coulometric determination without using a solvent, which also changes the sample weight from 1.0 to 2.0 g.

5. Revise the storage temperature from NMT 35° to ≤30° in the Packaging and Storage section.

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

 (EXC1: R. Challa)

 Case ID—SUB-2691