(10:00–11:30 EDT; 16:00–17:30 CEST)
Ethylene glycol and diethylene glycol testing: Approaches, requirements and recent individual and joint actions of the US Pharmacopeia (USP) and the European Pharmacopoeia (Ph. Eur.)
Program Overview
Ethylene glycol (EG) and diethylene glycol (DEG) contamination has been discovered in several medicinal products in African and Asian countries over the last 2 years (see recent WHO alerts). For example, confirmed cases of propylene glycol adulterated with EG have led to over 190 fatalities in Indonesia.1 In response, both the US Pharmacopeia (USP) and the European Pharmacopoeia (Ph. Eur.) have taken action to adress this public health risk.
This webinar will cover:
- the framework, approaches and requirements of both pharmacopoeias on controlling EG/DEG in excipient monographs;
- current individual and joint actions being taken by each pharmacopoeia;
- the background to the regional differences between the pharmacopoeias;
- the importance of stakeholder input and the opportunities for interaction.
The presentation will be followed by a live Q&A session.
1. Elanda Fikri, Yura Witsqa Firmansyah (2023). A Case Report of Contamination and Toxicity of Ethylene Glycol and Diethylene Glycol on Drugs in Indonesia. Environment and Ecology Research, 11(2), 378 - 384. DOI: 10.13189/eer.2023.110211.
Who Should Attend?
Professionals working in quality control/compliance, manufacturing and regulatory affairs, as well as in national regulatory agencies and inspection authorities.
Participation is free.