Full-service compendial release testing in state-of-the-art facilities
Our experienced scientific staff, extensive equipment capabilities, and streamlined processes can help you in releasing active pharmaceutical ingredients, excipients, and finished pharmaceutical products faster and more efficiently. Catalent provides full-service compendial release testing in a state-of-the-art facility to support pharmaceutical, biopharmaceutical GMP manufacturing at your facility, in Catalent’s network or at a third party site of your choice.
Global compendial release: Standard 10-business day turn-around time with rush services available for routine compendial analysis testing per current USP/NF, PhEur, JP/JPE, AOAC, ACS, DAB, FCC, and BP.
Customized release testing: Standard 10-business day turn-around time with rush services available for release of raw materials using your specified methodologies and specifications.
Establishment of release specifications: Regulatory and technical guidance in the establishment of release specifications for NCE's and new excipients.
General Chapter Testing
In addition to compendial release testing, Catalent also offers stand alone general chapter testing including:
- Elemental Impurities (USP<232> and <233>)
- Water determination by Karl Fischer(USP<921>)
- Particulate matter (USP<788> and <789>)
- Residual solvents (USP<467>)
- Containers (USP<660> and <661>)
- Nuclear Magnetic Resonance (USP<761>)
- Microbiological (USP <51>,<55>,<61>, <62>,<63>, <71> and <85>)
- Total Organic Carbon (USP<643>)
- Viscosity (USP<911>)
- Globule size distribution (USP<729>)
- Titrimetry (USP<541>)
- Thermal analysis (USP<891>)
- X-ray powder diffraction (XRPD) (USP<924>)
- Water Activity (USP<1112>)
Our experienced staff has a wide range of chemistry expertise to perform all type of testing including qualification of compendial method, as well as development, qualification and validation of new methods. Catalent wants to be your “lab down the hall” to provide the critical support you need no matter how large or small that need happens to be.