Extractables and Leachables Testing Services

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 <665>, <1663>, <1664>, and <1664>, EMA and extractables and leachables 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.

To learn more, visit our website:

www.intertek.com/pharmaceutical/analysis/extractables-leachables

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Intertek Analytical Services

  • GB
  • 2015
    On CPHI since
  • 4
    Certificates
  • 1000 - 4999
    Employees
Company types
CMO/CDMO
Consultancy
Contract Research Organisation (CRO)
Contract Service
Drug delivery device Supplier/Manufacturer
Manufacturer/Innovator
Primary activities
Analytical Services
Contract Research Organisation
Laboratory Services
Medical Devices
Packaging & drug delivery
Supply Chain
View company profile
Categories
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Specifications
  • Supplied from
    Switzerland; United States
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Sales Markets
Show more Show less

Intertek Analytical Services

  • GB
  • 2015
    On CPHI since
  • 4
    Certificates
  • 1000 - 4999
    Employees
Company types
CMO/CDMO
Consultancy
Contract Research Organisation (CRO)
Contract Service
Drug delivery device Supplier/Manufacturer
Manufacturer/Innovator
Primary activities
Analytical Services
Contract Research Organisation
Laboratory Services
Medical Devices
Packaging & drug delivery
Supply Chain
View company profile

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Intertek Analytical Services resources (2)

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    14 Sep 2022
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    Visit www.intertek.com/pharmaceutical for more information.