Extractables and Leachables Testing Services
Product description
Testing for extractables
and leachables: Our scientists perform
extractables and leachables testing based on regionally specific guidelines (EU,
US, China), nationally and internationally recognized standards (USP, ISO), GMP, PQRI recommendations, USP requirements (chapters <1663>, <1664>, and <1664.1>), and FDA guidelines.
Our experience in method development for controlled extractables studies and knowledge of leachable compounds, mean we can anticipate and identify potential sources of risk. We provide GMP leachables method validation and support a range of CCS or drug delivery systems such as pre-filled syringes, parenteral products, single use/disposable and bioprocessing equipment. Comprehensive evaluation and safety assessment review of laboratory E/L study data is performed by our in-house toxicologist consultants in order to identify and address potential risks and to assist with comprehensive impurity testing, whilst identifying gaps in existing data packages.
Learn more: www.intertek.com/pharmaceutical/analysis/extractables-leachables
Read more
Our experience in method development for controlled extractables studies and knowledge of leachable compounds, mean we can anticipate and identify potential sources of risk. We provide GMP leachables method validation and support a range of CCS or drug delivery systems such as pre-filled syringes, parenteral products, single use/disposable and bioprocessing equipment. Comprehensive evaluation and safety assessment review of laboratory E/L study data is performed by our in-house toxicologist consultants in order to identify and address potential risks and to assist with comprehensive impurity testing, whilst identifying gaps in existing data packages.
Learn more: www.intertek.com/pharmaceutical/analysis/extractables-leachables
Specifications
| Sales markets | Middle East Region (e.g. UAE); Oceania; North America (USA, Canada); Africa; Central America (e.g. Mexico); East Asia (e.g. China, Japan, Korea); Europe - EU countries; Europe - non EU (e.g. UK, Russia, ex-CIS countries); South America (e.g. Brazil, Colombia); South Asia (e.g. India, Pakistan, Sri Lanka); South East Asia (e.g. Thailand, Philippines, Singapore) |
|---|---|
| Supplied from | Switzerland; United States |
Extractables and Leachables Testing Services
Are you a supplier?
Here's what CPhI Online can do for you
- Generate quality leads for your business
- Stay visible for 365 days of the year
- Receive product inquiries and respond to meeting requests directly
- Improve company online presence through Search Engine Optimisation