Type of Posting: General Chapter Prospectus
Posting Date: 25–Oct–2024
Expert Committee: Excipient Test Methods (ETM)
Proposed New Title: <318> NMR Spectroscopy Monomer Ratio Determination for Lactide-Glycolide Polymers.
Input Deadline: 24–Nov–2024
Suggested audience: Excipient manufacturers, users and regulators
Estimated proposal PF: 51(5) [Sep.–Oct. 2025]
Background and objectives: Lactide-Glycolide or Lactic Acid-Glycolic acid polymers (LG polymers) are used extensively as excipients, including in complex extended-release drugs and medical devices . However, given the characterization and testing complexities of LG polymers and lack of standardized methods, their use in formulations and regulatory evaluation of LG polymer-containing drug products both remain challenging.
USP continues to seek solutions and provide both LG polymer compendial standards and other non-compendial solutions. USP’s compendial standards include Stimuli articles, monographs, and general chapters.
USP has introduced the NMR monomer ratio method for LG polymers to the first three LG polymer monograph PF proposals: DL-Lactide and Glycolide (50:50) Copolymer 12000 Acid in PF 48(3), DL-Lactide and Glycolide (50:50) Copolymer 12000 Ethyl Ester in PF 48 (6) and DL-Lactide and Glycolide (50:50) Copolymer 46000 Acid in PF 49 (5).
USP is proposing to cover this NMR method in a General Chapter for ease of reference in monographs and to broaden the applications of this method.
Description of scope and application: The scope of this General 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.
Preliminary outline:
- Introduction
- Procedure
- Solutions preparation (including standard and sample solutions)
- Instrumental system
- System suitability requirements
- Analysis
Anticipated activities: USP is requesting early input from stakeholders on this proposal of a new General Chapter <318> NMR Spectroscopy Monomer Ratio Determination for Lactide-Glycolide Polymers which is planned to be published for comments in Pharmacopeial Forum.
Contact: Peng Zhang, Ph.D., (301-692-3454, PGZ@usp.org)