Proposal for new USP Chapter <317> ICP OES Testing for Sodium Hydroxide and Potassium Hydroxide Published for Comments

In the Pharmacopeial Forum, PF 50(3), a proposal for a new General Chapter <317> ICP OES Testing for Sodium Hydroxide and Potassium Hydroxide was published. The text was developed by the Excipients Test Methods Expert Committee (ETM EC). Commenting is open until 31 July 2024.

The briefing notes state that "the proposal contains ICP-OES methods for the determination of Content of Sodium in Sodium Hydroxide and Content of Potassium in Potassium Hydroxide. The methods are based on the validated ICP-OES methods of analysis. Similarly, for the tests related to the estimation of potassium as an impurity in Sodium Hydroxide and sodium as an impurity in Potassium Hydroxide, an ICP-OES-based method is being proposed."

The Chapter is applicable to the analysis of sodium hydroxide and potassium hydroxide only. In the briefing notes, it is pointed out that the chapter does not cover analysis of other related excipients. Furthermore, "the methods in this general chapter are nonmandatory and are not part of Sodium Hydroxide and Potassium Hydroxide monograph specification in the absence of a reference in the General Notices, a monograph, or another applicable general chapter numbered below 1000."

The proposal is structured as follows:

• Methods
  - Content of Sodium in Sodium Hydroxide
  - Content of Potassium in Potassium Hydroxide
  - Potassium as an Impurity in Sodium Hydroxide
• Additional Requirements
  - USP Reference Standards <11>

The full text and further information are available via the USP website access point.