Compendial Testing

Certificates of Analysis (CoA) are often needed for US (CMC) and European (CTD) submissions to prove that the materials used are in compliance of US and European pharmacopoeias. Toxikon offers a wide range of compendial testing services in compliance with globally-recognized standards.

Pharmacopoeial Testing Services

Compendial Testing Standards

US (CMC) and European (CTD) submissions often need to contain Certificates of Analysis (CoA) to prove compliance of the materials to the current US and European pharmacopoeias, respectively. Toxikon offers a wide range of physicochemical, in-vitro and in-vivo pharmacopoeial testing.

  • United States Pharmacopoeia (USP) Testing
    • USP <87> In-Vitro Biological Reactivity – Cytotoxicity Testing
    • USP <88> In-Vivo Biological Reactivity – Class I–VI Testing
    • USP <381> Elastomers Closures for Injections
    • USP <661> Plastic Packaging Systems and Their Materials of Construction
    • USP <1663> Assessment of Extractables Associated with Pharmaceutical Packaging / Delivery Systems
  • US FDA – CFR Testing
    • CFR 176.2600 Rubber Articles Intended for Repeated Use.
    • CFR 177.2400 Perfluorocarbon Cured Elastomers
    • CFR 177.1520 Olefin Polymers
  • European Pharmacopeia (EP) Testing
    • 3.1 Series; Materials Used for the Manufacture of Containers
    • 3.2 Series; Containers
  • Japanese Pharmacopoeia (JP) Testing
  • International Organization for Standardization (ISO)
    • ISO 3826-1
    • ISO 3826-4
    • ISO 9626

Toxikon’s Expertise in Compendial Testing

Toxikon’s facilities and experienced laboratory management can offer the highest quality of work in compliance with ICH, OECD, ISO 17025 and many other globally-recognized standards.