USP-NF: Proposed Revisions to Polyethylene Glycol Monograph and Call for Stakeholder Feedback
The United States Pharmacopeial Convention (USP) develops and regularly updates USP–NF (United States Pharmacopeia and the National Formular) standards via a distinctive collaborative process that engages pharmaceutical scientists from various sectors, including industry, academia, and government, along with other stakeholders worldwide. The Complex Excipients Expert Committee intends to revise the USP Polyethylene Glycol monograph by including a Limit of Ethylene Glycol and Diethylene Glycol (EG/DEG) test in the Identification (ID) section to address the risk of EG/DEG contamination in Polyethylene Glycol.
Help the USP-NF and provide your feedback by answering a few questions through the link: Survey Questions
The current Polyethylene Glycol (PEG) monograph has no Identification test and there are two EG/DEG tests in the Impurities section for PEG MW < 450 and MW 450 – 1000, respectively. Unfortunately, both existing EG/DEG tests have some disadvantages that make them impractical for ID testing. USP has published a General Announcement to inform stakeholders of the anticipated future revisions to the Polyethylene Glycol monograph and to prepare industry for the potential operational and compliance implications that may be associated with this revision that may include a rapid implementation timeframe.
USP encourages stakeholders to provide feedback by October 30, 2023 on any impact that may result from these potential revisions; please direct any such feedback to the email [email protected]. You are also welcome to provide your feedback by answering a few questions through the link: Survey Questions
Read more
Source: USP-NF