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Category Archives: Extractable/Leachable

Share on Google+ November 12, 2018

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American Preclinical Services: Extractables and Leachables Program

Category : Analytical, Chemical Characterization, Extractable/Leachable, ISO

APS is a State of the Art, AAALAC and ISO17025 accredited, USDA registered and GLP compliant Contract Research Organization (CRO) located in Minneapolis, MN specializing in medical device and pharmaceutical testing. In addition to biocompatibility testing, interventional, surgical, toxicology, pharmacology, pain, physician training, bioskills, animal model development, and complete pathology services, APS has expended its services to include analytical services.

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Share on Google+ July 18, 2018

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E&L Chemical Characterization & Hexane Extracts: GC vs. LCUVMS Analysis

Category : Analytical, Chemical Characterization, Extractable/Leachable, Medical Device testing

As a contract laboratory providing extractables and leachables (E&L) services we are often asked about the time and cost required to perform chemical characterization of a medical device. Per FDA definition and guidance: Latest Guidance on Device Classification “Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers with micro-chip technology and laser surgical devices.” Herein lies the

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