Our scientists have experience in global pharmaceutical development. Your pharmaceutical product can be release-tested for global use at our facilities in the US or Europe. Clinical, registration, and commercial drug product lots are tested and monitored for shelf-life in our state-of-the-art stability chambers and are validated to meet ICH guidelines. We provide release data in a Certificate of Analysis.
Our Global Release Testing capabilities include:
- Compendial (USP, EP, and JP) testing of API and drug product
- HPLC
- Potency
- Impurities
- Identification
- GC
- Residual solvents
- Impurities
- Titration
- Acid-base
- Non-aqueous
- Moisture
- IR
- Hardness
- Particulate Matter
- Dissolution
- Using USP Apparatus 1, 2, 3, 4, 5, and 6 with HPLC or UV/Vis analytical finish
- Support for formulation development of solid dosage forms, including IR, ER, delayed release, encapsulated comparator products, and drug in capsule products