BRIEFING

 Glyceryl Mono- and Dipalmitostearate Type B. Because there is no existing NF monograph for this excipient, a new monograph based on validated methods is proposed.

 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-1722