The FDA Guidance defines leachables and extractables as materials or components derived from the container/closure that have been transferred into the contained drug substance or drug product. Enlist Covance, a recognized leader in development of validated methods to detect compound migration from packaging and closure systems when you need to identify compounds such as:

  • THF
  • PAH
  • Biphenols
  • Nylon
  • Nitrosamines

Characterize extractable, leachable materials or compounds that contaminate products and put you at risk. Covance brings full analytical support for quantitative and qualitative techniques to characterize your product's packages and closures for extractables/leachables from:

  • Adhesives
  • Dyes
  • Elastomeric compounds
  • Polymers used in your product's packages and closures

You gain Covance's extensive extractable, leachable experience working with a variety of products, including MDIs, DPIs, nasal sprays and parenteral (pre-filled syringe, IV bags and ocular) packages.

Voice of the Scientist

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Service Profile

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