Revision of USP <781> Optical Rotation
Recommendation

5/6 May 2026
Challenges and Solutions for Packaging / Devices & Single Use Systems
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
23.04.2026Revised Chapter 2.8.25 HPTLC of Herbal Products” Published in Ph. Eur. 13.1
22.04.2026USP plans new General Chapter on Supercritical Fluid Chromatography (SFC)
08.04.2026FDA Warning Letter: Batch Release Without Appropriate Laboratory Evidence
01.04.2026FDA Warning Letter - From Garbage Bags with Analytical Records to Pre-signed and Backdated Data
31.03.2026Questions and Answers on System Suitability Tests (SST) - Part 3
31.03.2026Statistical Process Control (SPC) - Survey Result Report now Available


