The field of drug analysis is an interesting and ever-changing one. There are constantly new impurities to be tested for, new regulations and new limits that must be observed in drug production. We keep an eye on the market for you and inform you about current developments here.
In 2022 and 2023 contamination with high levels of Diethylene Glycol (DEG) and Ethylene Glycol (EG) in oral liquid drug products were reported by numerous countries. These drugs included
- analygesic and
- antiemetic drug products,
and led to more than 300 fatalities, mostly in children under the age of 5.
Therefore, a series of warning letters was released by the FDA on August 3rd, 2023. According to the FDA, companies have failed to conduct identity testing to verify each component of their drug product. However, identity testing is mandatory according to 21 CFR 211.84(d)(1).
Drug safety is our responsibility, especially when children’s lives are at risk.
Reference Analytics is your reliable partner in identity testing! Together we can ensure drug safety for all consumers.
Summer is slowly passing, but analytical challenges remain!
The analysis of residual solvents can be tricky – so we’ve broken it down to 3 questions that drug manufacturers should ask themselves to ensure drug safety.
- What residual solvents were used in the production process?
- Are there residual solvents that interfere with each other during analysis?
- Can these solvent residues be determined in the same analytical procedure?
Our experts at Reference Analytics will be happy to help you answer these questions and work with you to find the right solution for your individual challenge. Contact us!