What is USP 661?
USP <661> refers to a set of analytical standards defined by the U.S. Pharmacopeia (USP) to help ensure the safety of a variety of health-related products when packaged in plastic containers. These products include pharmaceuticals, biologics, dietary supplements, and devices. The polymers outlined in USP <661> include high-density polyethylene (HDPE), low-density polyethylene (LDPE), polypropylene (PP), polyethylene terephthalate (PET), and polyethylene terephthalate G (PETG). In order for plastic packaging to be approved for use with an FDA-approved therapeutic product, data must show that the packaging conforms to USP <661> standards and performance criteria.
In 2016, the USP expanded the scope of the analytical standard to further support packaging safety. USP <661.1>, entitled ‘PLASTIC MATERIALS OF CONSTRUCTION’, introduces more rigorous standards and testing to demonstrate that packaging material is well-characterized and suitable for its intended use. USP <661.2>, entitled ‘PLASTIC PACKAGING SYSTEMS FOR PHARMACEUTICAL USE’, focuses on the products’ full packaging system. This includes the primary packaging that comes in contact with the pharmaceutical product as well as any secondary packaging. We are also able to provide guidance on the Chemical Safety Assessment required in the expanded chapter, including Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems 〈1663〉 and Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems 〈1664〉.
USP <661> Testing at EKG Labs
EKG Labs supports USP <661>, <661.1>, and <661.2> analytical testing for pharmaceutical, combination product, and medical device packaging. Our experience working with polymer materials and active ingredients uniquely positions us an industry leader in therapeutic product packaging testing. We understand the unique interactions that are possible when components come in contact with one another. EKG Labs will work to identify any impurities or degradants associated with the material contact and, if necessary, will help to identify alternative packaging materials.
USP <661> Analytical Techniques at EKG Labs
- Infrared Spectroscopy
- Differential Scanning Calorimetry
- Heavy Metals
- Nonvolatile Residue
- Total Organic Carbon
- Extractable Metals
Packaging Component Experience