BRIEFING

 Polyoxyl 15 Hydroxystearate. This proposal is based on the version of the monograph official as of May 1, 2020. On the basis of comments received, it is proposed to add the Limit of Ethylene Glycol and Diethylene Glycol test to the Impurities section. Polyoxyl 15 Hydroxystearate is one of the ethoxylated excipients covered in Ethylene Glycol, Diethylene Glycol, and Triethylene Glycol in Ethoxylated Substances 〈469〉. However, the existing ethylene glycol and diethylene glycol test procedure has certain limitations. The proposed Limit of Ethylene Glycol and Diethylene Glycol test employs a validated, more user-friendly gas chromatography (GC) method of analysis performed using the Restek Rtx-Wax column equivalent to G16 phase. The typical retention times for diethylene glycol and ethylene glycol are about 7.8 and 12.3 min, respectively. This proposed method applies to the revision of Polyethylene Glycol 40 Castor Oil [published via IRA official as of January 1, 2026], as well as to the Polyoxyl 35 Castor Oil and Polyoxyl 40 Hydrogenated Castor Oil monographs. Please see the updated proposals for the latter two monographs in the same Issue of PF.

 Additionally, minor editorial changes have been made to update the monograph to current USP style.

 (EXC2: A. Chang)

 Case ID—SUB-859