USP 661 Plastic Containers Testing

USP 661 Plastic Containers Testing 2019-03-06T19:29:50+00:00

Plastics are composed of a mixture of homologous polymers, having a range of molecular weights. Plastics may contain other substances such as residues from the polymerization process, plasticizers, stabilizers, antioxidants, pigments, and lubricants. Under the United State Pharmacopeia <661> General Chapter, five (5) specific types of plastics are profiled. Tests outlined in USP <661> are required to qualify your plastic container for use with pharmaceutical based products. Test procedures are based upon the specific type of plastic that the container is made from. The five USP plastics are High Density Polyethylene (HDPE), Low Density Polyethylene (LDPE), Polypropylene (PP), PET and PETG. Common identification tests for all plastics include the IR (multiple internal reflectance) and DSC (thermal analysis), which are compared to USP Reference Standards. Some sections of the test regimen are dependent of 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> Physico-Chemical Extractions (3 solvents)*

  • USP/NF Section <661> Polyethylene Containers (HDPE / LDPE)

  • USP/NF Section <661> Polypropylene Containers

  • USP/NF Section <661> PET & PETG Bottles

Whitehouse Laboratories operates a “Container Testing Center of Excellence”. The entire business unit brings multiple levels of experience to each container testing program. Staff members with specific areas of expertise are always available to consult on your testing needs.