Glyceryl Monostearate 50 Type A

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C₂₁H₄₂O₄ 358.56
Octadecanoic acid, monoester with 1,2,3-propanetriol [31566-31-1]

BRIEFING

Glyceryl Monostearate 50 Type A. 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 PL Gel brand of column with L21 packing. The relative retention times for triglycerides, diglycerides, monoglycerides, and glycerine are about 0.78, 0.81, 0.87, and 1.0, respectively.

(CE: R. Challa)

Case ID—SUB-444

USP REFERENCE STANDARDS FOR PURCHASE

USP Glycerin RS
USP Glyceryl Distearate RS

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