BRIEFING

 Polyoxyl 35 Castor Oil. 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 revise the test for Limit of Ethylene Glycol and Diethylene Glycol in the Impurity section, which is currently based on the existing procedure in Ethylene Glycol, Diethylene Glycol, and Triethylene Glycol in Ethoxylated Substances 〈469〉. To address the limitation of the current method, the proposed Limit of Ethylene Glycol and Diethylene Glycol method employs a validated gas chromatography (GC) method of analysis performed using the Restek Rtx-Wax column equivalent to phase G16. The typical retention times for diethylene glycol and ethylene glycol are about 7.8 and 12.3 min, respectively. This proposed method also 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 40 Hydrogenated Castor Oil and Polyoxyl 15 Hydroxystearate 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-866