Proposal for new USP Chapter <319> on NMR Block Length Determination
Recommendation
Monday, 21 September 2026 14.00 - 16.00 h
Regulatory Landscape: ECHA, USP, Pharmacopoeias and FDA Enforcement
On the Road to 30,000 Members
Let us become the World's Leading GMP/GDP Compliance Community in 2026
In Pharmacopeial Forum 52(1), a new USP General Chapter, <319> Nuclear Magnetic Resonance Spectroscopy Block Length Determination for Lactide–Glycolide Polymers has been published for comment..
At the end of October 2025, USP had already published a general chapter prospectus outlining the background and rationale for the development of this chapter.
The proposal notes that “block length is a critical property for understanding and controlling the composition and variability of excipients during formulation development, manufacturing, and testing of lactide–glycolide and lactic acid–glycolic acid polymers (PLGs and PLGAs).” The chapter describes a 13C nuclear magnetic resonance (13C-NMR) method to determine the glycolate block length in lactide–glycolide polymers that are ring-opening copolymers of DL-lactide and glycolide.
The proposal is available free of charge on the Pharmacopeial Forum website, and comments can be submitted until 31 May 2026.
Related GMP News
03.09.2026USP Article: Supporting the Detection of Asbestos in Pharmaceutical Talc
02.09.2026USP Publishes Comments Received on Chapter <320>
26.08.2026New USP Requirements for Asbestos Testing in Pharmaceutical Talc
19.08.2026FDA Warning Letter: Averaging Data to Override OOS Findings
12.08.2026ECA's Analytical Control Group Publishes Detailed Report on OOS Survey
12.08.2026BP Publishes Key Insights on Limits in Chromatographic Tests