Challenges of Extractables & Leachables Experience

The investigation of the chemical compatibility between a drug product and its container relates to drug product quality, efficacy and safety - critical parameters for the development and commercialisation of a drug product. This implies assessing the extractables and leachables for each new drug product before submission for marketing authorization, and to re-evaluate requirements for each variation of an existing drug product. A 'Toxicological Risk Assessment' must also be conducted to evaluate patient exposure to chemicals over shelf-life and it is the responsibility of a Pharmaceutical company to provide timely evidence on the quality of their finished product. Tools & methodology for E&L studies can be deployed to anticipate challenges and provide key data to de-risk your drug combination product development, even at an early stage.