Critical Design Strategies For Extractables And Leachables Control

Author: Thomas Feinberg

Summary: Extractable and leachables from within a drug’s packaging can make their way into the drug productitself. While it is rare for products to become adulterated in this manner, it can and does happen, and thus it is essential that effective tests are carried out to detect and, if necessary, identify and quantify the levels of extractable and leachable substances that may be present in a drug dosage form. Learn more about:

  • Extractable and leachable detection methods and best practices.
  • Designing a testing strategy for success.
  • Testing challenges and containment dangers. 

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