Compendial and Pharmacoepial

Smithers Rapra can perform a variety of tests on your packaging materials to ensure that the product contained remains fit for intended use.

The packaging used for drug products is fundamental to their integrity and long term stability. Containers may need to protect the drug product from the effects of moisture, oxygen and light, whilst substances which may leach from the packaging material must not affect the safety or efficacy of the drug.

The various Pharmacopoeia include chapters and monographs which prescribe how the physicochemical properties of packaging materials and their permeability should be assessed. Smithers Rapra can perform these tests on your packaging materials and containers:

  • USP <1663> (Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems)
  • USP <1664> (Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems)
  • USP <232> (Elemental Impurities)
  • USP <381> (Elastomeric Closures for Injections)
  • USP <661> (Containers – Plastic)
  • USP <671> (Containers – Performance Testing)
  • Ph Eur 3.1 to 3.1.15 (Materials used for the Manufacture of Containers)
  • Ph Eur 3.2 (Containers), e.g. 3.2.2 to 3.2.6
  • Ph Eur 3.2.8 (Sterile Single Use Plastic Syringes)
  • Ph Eur 3.2.9 (Rubber Closures)
  • JP (Test for Rubber Closure)
  • JP (Test Methods for Plastic Containers)
  • Various other monographs and chapters

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