BRIEFING

 Glyceryl Mono- and Dipalmitostearate Type A. Because there is no existing NF monograph for this excipient, a new monograph based on validated methods is proposed. Previously, this monograph proposal was published in PF 50(4) [Jul.–Aug. 2024] with the title "Glyceryl Monostearate 50 Type A" and never became official in NF. On the basis of comments received from external stakeholders, the title is revised to "Glyceryl Mono- and Dipalmitostearate Type A".

 The chemical information section is removed from the earlier proposed version as this excipient is a mixture of various mono- or diesters of glycerol that can have multiple combinations with no defined structure, molecular formula, or molecular weight.

 The gel permeation chromatographic procedure in the Assay is based on analyses performed with the Agilent PLgel brand of column with L21 packing. The relative retention times for triglycerides, diglycerides, monoglycerides, and glycerin are about 0.78, 0.81, 0.87, and 1.0, respectively.

 (CE: R. Challa)

 Case ID—SUB-2089