BRIEFING

 Polyoxyl 20 Cetostearyl Ether. 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 make the following changes:

1. In the test for Free Ethylene Oxide, replace the current packed column gas chromatographic procedure with the test from Ethylene Oxide and Dioxane 〈228〉, Method II and tighten the specification limit from NMT 0.01% to NMT 1 µg/g. Most of the ethoxylated excipients in NF have the specification set at NMT 1 µg/g for free ethylene oxide.

2. Add a free dioxane test using the test from Ethylene Oxide and Dioxane 〈228〉, Method II and set the Acceptance criteria at NMT 10 µg/g.

3. Please note that there was a revision published in PF 49(3) [May–Jun. 2023] in the test for Water Determination. The specification changed from NMT 1.0% to NMT 3.0% for water content.

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

 (CE: A. Chang)

 Correspondence Number—C317341; C324026