Revision of USP <781> Optical Rotation
Recommendation
Tuesday, 4 February 2025 9 .00 - 17.00 h
Establishment, Use and Maintenance of Analytical Reference Substances
In the current Pharmacopeial Forum, PF 47(3), a proposal of USP Chapter <781> Optical Rotation has been published for comments.
The proposal is based on the version of the monograph official as of December 1, 2017. According to the USP, the previous proposal in PF 46(3) has been canceled. The text has been revised to address comments received.
Besides minor editorial changes to update the chapter to the current USP style, the revisions to the chapter include the following:
- Clarifications concerning the equation for specific rotation were incorporated.
- A new section on Qualification of Polarimeters was added.
- The reported optical rotation using visual polarimeters and replicate measurements has been removed.
Comments on the chapter can be submitted from now on. The comment deadline is July 31, 2021.
The draft chapter USP <781> Optical Rotation can be viewed here. (Please note: a one-time registration is required to access the Pharmacopeial Forum.)
Related GMP News
20.01.2025USP Chapters <31> and <1331> on Volumetric Apparatus again Published for Comments
20.01.2025USP-NF Stimuli Article on Apex Vessels used in Dissolution Testing
20.01.2025Pharmeuropa: New Chapter 2.5.45 on Photoionisation Detectors published for Comments
15.01.2025English Translation of Supplement II to the Japanese Pharmacopoeia (JP18) Published
08.01.2025EDQM publishes new FAQ on System Suitability Test (SST)