USP Seeks Early Input on Proposed New General Chapter <318>
Recommendation
5/6 February 2025
Register now for ECA's GMP Newsletter
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.
Related GMP News
04.11.2024FDA Publishes Guideline on Bioequivalence for Immediate-Release Solid Oral Dosage Forms
16.10.2024US FDA Warning Letter: Lab Data Integrity issues
16.10.2024FDA Warning Letter: Component Testing, Validation, and Stability
16.10.2024EDQM publishes New Chapter "Quality of Data" for Comments
16.10.2024USP Chapter <621> Chromatography: Notice of Intent to Revise