Extractables & Leachables Testing
Characterization of Materials for Extractable and Leachable Components for Pharmaceutical, Biopharmaceutical and Medical Device Industries
The need for Extractables & Leachables data continues to expand during product development across industries. Not only known additives (dyes, antioxidants, plasticizers and stabilizers, metals), but also other unknown chemicals present, could lead to patient exposure causing safety concerns. Be sure your products are safe for use during product development.
Impact Analytical has extensive experience performing Extractables and Leachables studies on many materials including packaging components, container closure systems, medical devices, pre-filled syringes as well as manufacturing/processing equipment. We have proprietary methods developed for efficient extraction, unknown identification and accurate quantitation of extractables in many material types. We can tell you not only what could potentially be extracted from product materials, but how much of any leachable component patients could be exposed to. Studies are conducted in FDA registered and cGMP compliant laboratories using the latest technologies to detect trace levels.
Extractables & Leachables Support
- Strategic approach and study design based on the specific materials and application
- Controlled extraction study performance
- Characterization and identification of organic and inorganic extractables using state-of-the-art analytical techniques (HPLC, LC-MS, GC-MS, ICP, UPLC)
- Method development and validation for the determination of potential leachables in pharmaceutical and medical device products
- Leachables studies using validated method(s) to support product Stability programs