U.S. Pharmacopeia Testing (USP)

The team at Smithers Rapra can perform a range of testing procedures to USP standards, in our FDA registered analytical laboratories.

Performing testing to USP standards enables our clients to demonstrate regulatory compliance for their drug products and medical devices.

These tests include:

  • USP <1661> Evaluation of Plastic Packaging Systems and Their Materials of Construction with Respect to Their User Safety Impact
  • 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 <661.1> Plastic Materials of Construction
  • USP <661.2> Plastic Packaging Systems for Pharmaceutical Use
  • USP <665> Plastic Components and Systems Used in Pharmaceutical Manufacturing
  • USP <671> (Containers – Performance Testing)

We can tailor a bespoke testing programme around your requirements, and can combine our USP testing with a variety of other medical device testing services such as device testing, packaging testing or transit studies.

Contact us to find out more >