USP Seeks Early Input on Proposed New General Chapter <318>

On 25 October 2024, the USP published a General Chapter Prospectus for a new USP General Chapter <318> on NMR Spectroscopy Monomer Ratio Determination for Lactide-Glycolide Polymers.

The scope of the new chapter will include NMR methods for determination of monomer ratio for the LG polymers that are ring-opening copolymers of DL- or L-lactide and glycolide. The preliminary outline is as follows:

• Introduction
• Procedure
  - Solutions preparation (including standard and sample solutions)
  - Instrumental system
  - System suitability requirements
  - Analysis

The USP is requesting early input from stakeholders on this proposal, with an input deadline of 24 November 2024. The text is planned to be published for comments in Pharmacopeial Forum 51(5) in September 2025.

For further information, please see the post on the USP-NF website.