Extractable and leachable testing

Extractable and leachable testing
Product Description

Pace analytical life sciences llc offers wide range of services which includes extractable and leachable testing service. It has developed a comprehensive approach towards extractable and leachable testing. Its study identify extractables, compounds that can be extracted from a component under extreme conditions, and leachables, compounds that leach into a drug product from a component in direct contact with it under normal conditions. It may be composed of both organic substances and inorganic substances typically coming from plastic components, elastomers, coatings, accelerants, antioxidants, inks and vulcanizing agents. It is particularly relevant to pharmaceutical and medical device packaging where safety and packaging toxicology is being scrutinized. Testing is also important in the medical device industry when biocompatibility testing and material toxicology is being evaluated. Contact us for more information.

Pace Life Sciences, LLC

  • US
  • 2017
    On CPHI since
  • 4
    Certificates
  • 250 - 499
    Employees
Company types
Contract Service
Specifications
  • Selling Points
    Quality Service
  • Supplied from
    United States

Pace Life Sciences, LLC

  • US
  • 2017
    On CPHI since
  • 4
    Certificates
  • 250 - 499
    Employees
Company types
Contract Service

More Products from Pace Life Sciences, LLC (16)

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  • Bioburden testing

    Product Bioburden testing

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  • Biological indicator testing

    Product Biological indicator testing

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  • Elemental metals / elemental impurities

    Product Elemental metals / elemental impurities

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  • Endotoxin testing

    Product Endotoxin testing

    Pace analytical life sciences llc offers wide range of services which includes endotoxin testing service. It provides endotoxin testing for the pharmaceutical, biopharmaceutical and medical device industries. This test is also known as the limulus amebocyte lysate, or lal, test. It follow usp bacterial en...
  • Environmental monitoring services

    Product Environmental monitoring services

    Pace analytical life sciences llc offers wide range of services which includes environmental monitoring services service. It covers a range of areas requiring microbiological testing to detect changing trends of microbial counts and micro-flora growth within the manufacturing environments. In aseptic manuf...
  • Facility validation support

    Product Facility validation support

    Pace analytical life sciences llc offers wide range of services which includes facility validation support service. It provides with a comprehensive range of analytical services to support the validation of pharmaceutical facilities. Its analytical testing services provide support for the validation of pur...
  • Method development and validation

    Product Method development and validation

    Pace analytical life sciences llc offers wide range of services which includes method development and validation service. It provides senior level, highly experienced scientists dedicated to performing method development and validation services. Areas of expertise include: stability-indicating assays / imp...
  • Microbial limits test

    Product Microbial limits test

    Pace analytical life sciences llc offers wide range of services which includes microbial limits test service. It is performed by life sciences meet the requirements of usp , which are harmonized with ep chapters 2.6.12 and 2.6.13 and jp requirements. Has experience with a wide range of raw materials and pr...
  • Particulate analysis service

    Product Particulate analysis service

    Pace analytical life sciences llc offers wide range of services which includes particulate analysis service. It provides particulate analysis testing for the pharmaceutical, biopharmaceutical and medical device industries. Its particulate analysis, or particulate-particle testing, follows usp testing meth...
  • Sterility test service

    Product Sterility test service

    Pace analytical life sciences llc offers wide range of services which includes sterility test service. It has demonstrated experience with a wide range of dosage forms, including terminally sterilized parenterals, compounded products, medical devices and combination products. Performs traditional membrane ...
  • Extractables and Leachables

    Product Extractables and Leachables

    Pace® Life Sciences has developed a comprehensive approach towards extractable and leachable testing. We design studies to identify extractables, compounds that can be extracted from a component under exaggerated conditions, and leachables, compounds that could migrate into a drug product or patient during...

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