In the pharmaceutical industry, excipients can make up as much as 90% of a drug product, meaning their quality and safety are just as crucial as that of APIs. The misconception that excipients are "inactive" can lead to overlooking potential risks, such as contamination from impurities or recycled solvents.
A tragic example of excipient contamination is the 1995 Haiti incident, where 88 children died due to diethylene glycol poisoning in cough syrup. This, along with similar events, highlighted the need for rigorous excipient testing. Regulatory agencies, such as the FDA, have since developed stricter guidelines and methods for excipient safety. Testing laboratories like Butterworth have taken on the responsibility of ensuring both APIs and excipients meet pharmacopeial standards.
Butterworth Laboratories offers excipient testing services that guarantee compliance and safety in pharmaceutical manufacturing.
To read more about the importance of excipient testing, click HERE to access our white paper.
