BRIEFING

 Diethylene Glycol Stearates. This proposal is based on the version of the monograph official as of June 1, 2022. On the basis of comments and data received and to align with the corresponding European Pharmacopoeia 11.0 monograph for Diethylene Glycol Palmitostearate, it is proposed to make the following revisions:

1. Update the Definition to specify Stearic Acid 50 as a raw material for production of Diethylene Glycol Stearates and the percentages of monoesters and diesters.

2. Add Identification C based on the HPLC procedure in the Assay. Diethylene Glycol Stearates should meet the requirements for the content of mono- and diesters.

3. Update the equation for calculating the percentage of monoesters in the Assay to correct for water content. Add an equation to the Assay to calculate the percentage of diesters, corrected for water and the amount of free diethylene glycol.

4. Change the acceptance criteria for diethylene glycol in the Limit of Free Diethylene Glycol test from 8.0% to 2.5%.

5. Change the lower limit in the acceptance criteria in the test for Saponification Value from 150 to 155. The increase in the lower limit of saponification value is the result of reduction in free diethylene glycol in Diethylene Glycol Stearates.

6. Add a test for Water Determination.

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

 (CE: G. Holloway)

 Correspondence Number—C276555