Extractables and Leachables Testing

Extractables and Leachables Testing
Product Description

Our experts have over 30 years of experience in specialized analytical and toxicology assessment for extractable leachable testing. Intertek offers extractables and leachables testing services through GMP-compliant laboratories located in Whitehouse, NJ (USA) and Basel (Switzerland) with research support from our Mumbai (India) facility, as part of our commitment to Total Quality Assurance. 
Our E&L expertise reinforced by our knowledge of polymer, plastic and packaging materials, allowing us to identify components from the most complex polymer formulation including adhesives, additives and stabilizer ingredients and their degradation products. Our consultants provide first-class evaluation and assessment of existing E&L data gaps, and...

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Intertek

  • US
  • 2017
    On CPHI since
  • 4
    Certificates
  • 5000+
    Employees
Company types
CMO/CDMO
Contract Research Organisation (CRO)
Contract Service
Primary activities
Analytical Services
Biopharmaceutical
Contract Research Organisation
Laboratory Services
Medical Devices
Packaging & drug delivery
View company profile
Categories
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Specifications
  • Details
    Our scientists conduct E&L analysis studies in accordance with regional guidance and nationally/internationally recognized standards including Good Manufacturing Practice (GMP), Product Quality Research Institute - PQRI extractables and leachables guidelines, United States Pharmacopeia (USP) requirements (e.g. USP extractable and leachable USP chapters <665>, <1665>, <1663>, <1664>, and <1664.1>), European Medicines Agency (extractables and leachables EMA guidance), US Food and Drug Administration, FDA extractables and leachables guidance, the BioPhorum/ BPOG Guidance, and ISO 10993-18 extractables and leachables guidelines (Part 18). 
  • Selling Points
    Experienced Technicians; Extractables and leachables testing to quantify and assess risks associated with leachable impurities from pharmaceutical container closure systems (CCS), process equipment or medical device packaging
  • Supplied from
    India; Switzerland; United States
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Sales Markets
Show more Show less

Intertek

  • US
  • 2017
    On CPHI since
  • 4
    Certificates
  • 5000+
    Employees
Company types
CMO/CDMO
Contract Research Organisation (CRO)
Contract Service
Primary activities
Analytical Services
Biopharmaceutical
Contract Research Organisation
Laboratory Services
Medical Devices
Packaging & drug delivery
View company profile

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