BRIEFING

 Polyethylene Glycol 60 Hydrogenated Castor Oil. Because there is no existing NF monograph for this excipient, a new monograph based on validated methods of analysis is proposed. The Polyethylene Glycol 60 Hydrogenated Castor Oil monograph was developed individually to align with the FDA Inactive Ingredient Database (IID) and Global Substance Registration System (GSRS), although there are other types of similar excipients (e.g., polyoxyl 40 hydrogenated castor oil). The Identity by Fatty Acid Composition test is based on a validated gas chromatographic method of analysis performed with the Agilent DB-WAX brand of column with G16 phase. The typical retention times for methyl palmitate, methyl stearate, methyl arachidate, methyl 12-ketostearate, and methyl 12-hydroxystearate are approximately 6.5, 8.9, 13.1, 20.4, and 24.0 min, respectively.

 (CE: P. Zhang)

 Correspondence Number—C262836