To qualify your plastic container for use with pharmaceutical-based products, we provide specialized testing procedures based upon the specific type of plastic that the container is made from. The United States Pharmacopeia <661> General Chapter profiles five types of plastics that require testing: high density polyethylene (HDPE), low density polyethylene (LDPE), polypropylene (PP), polyethylene terephthalate (PET) and polyethylene terephthalate glycol-modified (PETG).

We conduct routine identification tests for all plastics. These include IR (multiple internal reflectance) and DSC (thermal analysis), which we then compare to USP Reference Standards. Some sections of the test regimen depend on whether the container will hold a liquid or a solid product.

Specific test procedures and general chapter sections include:

  • USP/NF Section <661> Physicochemical Plastic Container Testing
  • USP/NF Section <661> Thermal Analysis
  • USP/NF Section <661> Multiple Internal Reflectance
  • USP/NF Section <661> Physicochemical Extractions (three solvents)
  • USP/NF Section <661> Polyethylene Containers (HDPE/LDPE)
  • USP/NF Section <661> Polypropylene Containers
  • USP/NF Section <661> PET & PETG Bottles
  • USP<661.1> Plastic Materials of Construction- Mostly all materials of Construction- Identification (IR and DSC), Physicochemical tests, Extractable Metals, Plastic Additives
  • USP<661.2> Plastic Packaging System for Pharmaceutical use-Physicochemical tests

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