Revised USP General Chapter <781> Optical Rotation published for Comments

Recommendation

20-22 June 2023
Barcelona, Spain

GMP & GDP Forum 2023
Day 1, 2 and 3

In the Pharmacopeial Forum, PF 49(3), a proposal of a slightly revised USP General Chapter <781> Optical Rotation has been published for comments.

The new proposal is based on the version of the chapter official as of 01 December 2022. According to the briefing notes, besides minor editorial changes to update the chapter to the current USP style, the revisions serves "one primary purpose, to change the requirements of relative standard deviation (%RSD) to standard deviation in the Repeatability section under Operational Qualification (OQ)."

Instead of "Calculate the relative standard deviation (% RSD) of the replicates" the text now says: "Typically, the same reference standard or certified reference material used in Accuracy of Optical Rotation is used to assess repeatability. Calculate the variability of the replicates, typically expressed as standard deviation."

Comments on the revised chapter can be submitted from now on. The comment deadline is 31 July 2023.

The draft is available after registration to the Pharmacopeial Forum.