Type of Posting: General Chapter Prospectus
Posting Date 29–Jan–2021
Expert Committee Excipient Test Methods (ETM)
Proposed New Title: <313> Molecular Weight and Polymer Chain Length Determination for Polypropylene Glycol Fatty Ethers
Input Deadline: 28–Feb–2021
Suggested audience: Excipient manufacturers, users and regulators
Estimated proposal PF: 47(6) [Nov.–Dec. 2021]
Background and objectives:
During the 2015-2020 Excipients Expert Committees (ECs) Science Strategy discussions, excipient ECs set the following as a key strategy:
- advancing the understanding and control of excipient composition and variability during formulation development, and
- manufacturing and testing of pharmaceutical excipients.
USP excipient program unit initiated many internal research lab projects for development and validation of methodologies using advanced technologies for compositional analysis of complex excipients, especially existing polymeric excipients that lack specific testing. These technologies include Gel Permeation Chromatograph (GPC)/Size Exclusion Chromatograph (SEC) and NMR.
In the 2020-2025 revision cycle, the ETM EC is proposing to introduce these analytical methods through a general chapter approach.
Description of scope and application:
The scope of this general chapter will include the following:
- GPC/SEC method for determination of average molecular weight and polydispersity for polypropylene glycol fatty ethers
- Proton NMR method for determination of average polymer chain length for polypropylene glycol fatty ethers
The general chapter is intended to be applicable for compositional analysis of polypropylene glycol (PPG) fatty ethers and potential polyethylene glycol (PEG) derivatives or PPG derivatives.
Preliminary outline:
Each method will include the following sections:
- 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 chapter General Chapter <313> Molecular Weight and Polymer Chain Length Determination for Polypropylene Glycol Fatty Ethers which is planned to be published for comments in Pharmacopeial Forum.
Contact: Peng Zhang, Ph.D., (301-692-3454, PGZ@usp.org)
CN-21-033-00