USP publishes Comments rereived on Chapter <317>

In its recently published USP–NF 2026 Issue 1 Commentary, posted on 25 July 2025, the United States Pharmacopeia (USP) addressed public comments received on the draft of General Chapter <317> ICP-OES Testing for Sodium Hydroxide and Potassium Hydroxide. The chapter was originally proposed in Pharmacopeial Forum, PF 50(3), and aims to introduce validated ICP-OES methods for the determination of content of sodium in sodium hydroxide and content of potassium in potassium hydroxide.

The Expert Committee on Excipients Test Methods received two comments during the consultation phase. One request sought greater flexibility in the choice of diluent and calibration procedures for the method. Another comment suggested revising the description of the diluent.

While the first comment was not adopted, USP partially accepted the second and updated the diluent specification in the draft to read: 1% Hydrochloric acid, Ultratrace in deionized water at least 18 MΩ." thereby aligning with USP’s reagent definitions and Chapter <1730>.

It is important to note that Chapter <317> remains a non-mandatory informational chapter unless explicitly referenced in a monograph or in the General Notices. It applies specifically to sodium hydroxide and potassium hydroxide, and not to other excipients.