BRIEFING

 Isostearic Acid 75. Because there is no existing NF monograph for this excipient, a new monograph based on validated methods of analysis is proposed.

 The gas chromatographic procedure in the Assay is based on analyses performed with the Agilent DB-WAX capillary brand of column with G16 stationary phase. The typical retention times for methyl palmitate, methyl stearate, and methyl oleate are about 26.26, 29.94, and 30.31 min, respectively.

 (CE: R. Challa)

 Correspondence Number—C312316