Ethylene and Diethylene Glycol Testing - Webinar Recording

Course No. 21806



Alexander Doppelreiter

Alexander Doppelreiter

Reference Analytics

Jenny Liu

Jenny Liu

USP - United States Pharmacopeia


Recent events have highlighted the serious risks posed by the contamination of medicines with diethylene glycol (DEG) and ethylene glycol (EG), particularly in children. A notable case occurred between June and September 2022 in Gambia, where children developed acute renal failure after being administered medicines that were later found to contain DEG and EG. This led to a rapid public health response, including the suspension of the use of all paracetamol and promethazine syrups and a recall of the contaminated products. The World Health Organisation (WHO) issued a global alert on the affected medicines from Maiden Pharmaceuticals Limited, India. Investigations directly linked the Acute Kidney Injury (AKI) cases to the contaminated syrups, emphasising the critical importance of strict quality management in the manufacture and regulation of medicines.

The WHO has called for urgent action following reports of over-the-counter cough syrups for children contaminated with high levels of DEG and EC in at least seven countries, resulting in more than 300 deaths. These incidents underscore the need for immediate and coordinated action by all stakeholders in the medical supply chain, including regulators, manufacturers, suppliers and distributors, to detect and eliminate substandard medical products, ensure the approval and safe sourcing of medical products, and improve surveillance and risk-based inspections.

In response to these concerns, the US Food and Drug Administration (FDA) has issued new guidance for the pharmaceutical industry on testing for EGs and DEGs in high-risk drug components. This guidance was prompted by WHO global health alerts about contaminated drugs in countries such as Indonesia, Gambia and Uzbekistan. EG and DEG are highly toxic substances used in industrial applications such as antifreeze and should never be included in medicines. Their contamination in liquid oral drugs has been linked to serious health consequences, including central nervous system (CNS), heart and kidney damage and even death. The FDA guidance aims to limit EG and DEG content in high-risk drug ingredients to no more than 0.10%, with a focus on glycerine, propylene glycol and certain sugar polyol solutions that have been contaminated in the past. This initiative emphasises the need for stringent testing and quality assurance measures in the manufacture and distribution of medicinal products.

The importance of this can also be seen in the number of warning letters issued by the FDA and the activities of other organisations such as the USP and WHO.

Target Group

This webinar addresses itself to all, which are involved in quality control of incoming goods, starting material or release of final drug product.
  • It will be of significant value to analytical laboratory managers and their colleagues,
  • Analytical scientists,
  • QA, manufacturing and supply chain professionals.

Technical Details:

To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.

Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.

Please be aware: The recording does not include the Q & A sessions.

Training Course Documentation and Certificate:
The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.


This webinar will give in two talks and a following Q&A session an overview of the impurities, possible sources and analytical strategies as well as USP’s effort on EG/DEG testing.

Importance of Excipient Quality – USP’s Effort on DEG/EG Testing of High-Risk Excipients
  • USP mission and role; Importance of Excipient Quality
  • History of DEG poisoning incidents and the Food, Drug &
  • Cosmetic Act (Difference between Identification and Impurity tests)
  • USP DEG/EG efforts: progress and challenges
  • Next steps
Jenny Liu, Principal Scientist at USP

Analysis of the Current Warning Letters and Analytical Testing
  • Content of current FDA warning letters
  • Possible sources of contamination
  • Laboratory Testing
Alexander Doppelreiter, CEO, Head QC bei Reference Analytics

Recording from 28 May 2024
Duration of Recording: 59 min.

ECA-Member*: € 349,-
Regular Fee*: € 399,-

(All prices excl. VAT). Important notes on sales tax.

* also payable by credit card
American Express Visa Mastercard

Further dates on-site
Further dates on-site
Not available
Further dates online
Further dates online
Not available

Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0

Woman with headset

Go back

Testimonials about our courses and conferences

“Fantastic course – I really enjoyed the interactive structure & greatly appreciate social activity.”

Anthony Cummins, Sebela Pharmaceuticals, Ireland
GMP Auditor Practice, September 2023


“Very well organized, information on point without being overwhelming.”

Eleni Kallinikou, Pharmathen
Live Online Trainng - Pharmaceutical Contracts - Febuary 2024


“Good overview of different types of agreements, good to see both the GMP and the legal angle”

Ann Michiels, Johnson&Johnson
Live Online Trainng - Pharmaceutical Contracts, Febuary 2024



“Well prepared presentations and good presenters. I also like the way of asking questions.”

Alexandra Weidler, Hookipa Biotech GmbH, Austria
Live Online Training – QP Education Course Module A, November 2023