A Reminder of the Importance of Excipient Testing

2 November 2023

In our April News Bulletin, we highlighted an Article and White Paper written by our Associate Director, John Welch on the importance of the testing of excipients used in the manufacture of medicines.  In both of these publications, John referenced the example of cough syrup which was manufactured by an Indonesian company between 2021 and 2022 and which was contaminated by Ethylene Glycol. The unfortunate and very sad outcome was the death of hundreds of Children in Indonesia, The Gambia and Uzbekistan.

It was interesting to read today that the managers of the firm which manufactured the cough syrup have been fined and sentenced to jail for the incident.  Their failure was simple:  Between October 2021 and February 2022, their company received batches of Propylene Glycol to be used in the manufacture of their product.  Unfortunately, these batches mostly contained Ethylene Glycol (at reported concentrations of 96 – 99%) which is toxic.  Because they relied on the supplier’s certification rather than independently testing these batches themselves, this toxic material ended up in a medicine intended for children. 

Whilst reading about this, another recent article which appeared on the BBC News website came to mind about an event with striking similarities.  This time it involved the sale of Humbug sweets at Halloween which caused countless deaths in Bradford way back in 1858.  The culprit was Arsenic which had been added to the sweet mixture in error due to the supplier confusing a bag of Arsenic with a bag of the intended harmless ingredient.  Now, I know that Humbugs are not medicinal products and there would have been no requirements for testing any of the ingredients, but this event does show that terrible mix-ups can occur and when they do, having robust testing regimes for all the materials used in the process of drug manufacture can protect the health of the end-user and ultimately save lives.

Butterworth Laboratories has a well-established reputation for the testing of excipients in support of the manufacture of pharmaceutical products.   Often the testing is less routine than the batch testing of the finished product due to the frequency and quantities that raw materials are purchased. Because of this, it can be more effective to outsource this valuable testing. 

Why not get in touch to see how we can help support you in your excipient testing needs? business@butterworth-labs.co.uk