Clarity at the chemical level
Extractables and leachables can introduce hidden risk into drug products and medical devices if not properly understood and controlled. Our comprehensive chemical characterization services help identify compounds that may migrate from materials, components, or packaging systems to protect both product integrity and patient safety.
We apply a science-driven, risk-based approach to extractables and leachables analysis, informed by global guidance and real-world manufacturing considerations. By combining worst-case extraction studies with advanced analytical techniques, our experienced teams generate meaningful, defensible data that supports risk assessment, regulatory submissions, and long-term product safety strategies.
Our extractables and leachables services include:
- Extractables studies: Worst-case chemical characterization using exaggerated conditions to identify potential organic and inorganic compounds.
- Leachables screening studies: Targeted, quantitative screening of aged product for extractable compounds leaching over into the product.
- Method development and validation: Evaluation of leachable control methods for formal leachable stability studies.
- Risk assessments: Unbiased support facilitating risk assessments for extractables and leachables from manufacturing processes per USP <1665> and USP <665>.
- Stability studies: Accelerated and long-term studies to assess potential leachables under real-use conditions.
