Drug Release & Stability TestingSource: Patheon Inc.
Patheon gives you access to a broad range of technologies for in-process and release testing, as well as stability studies, for drug substances, developmental formulations and clinical trial materials in support of IND, IMPD and other early-phase clinical studies.
With the experience of hundreds of projects, we have the expertise to get your project to Phase I studies and beyond as quickly as possible.
Patheon is fully integrated like no other organization. The scientists performing your studies will be in direct communication with the scientists working on your project's development and clinical trial material manufacturing. By being able to share data, and easily coordinate planning and scheduling, our team can deliver maximum efficiency and on-time performance.
In-process and release tests at Patheon
- ID (HPLC, TLC, UV, FTIR)
- Physical testing: LOD, Appearance, Color, Weight variation, Viscometry, Deliverable Volume
- Particle size by laser diffraction (wet and dry sampling)
- XRPD, TGA, DSC
- Wet chemistry tests (USP, EP, JP)
- Assay (UPLC, HPLC, GC) and related substances
- Anti-oxidant/Preservative assay
- Chiral analysis
- Content and Blend Uniformity
- Genotoxic Impurity Analysis (LC/MS)
- Residual solvents (OVI)
- KF (Volumetric, Coulometric),
- Dissolution: Immediate Release & Enteric Coated – USP Apparatus I & II (1- and 2-stage dissolution profiles), III, IV and VII
- Metal content (ICP, AA)
- Microbial testing (MLT, MET, sterility)
Stability testing at Patheon
- Conventional and specialized, solid and sterile dose forms
- High-potency products and controlled substances
- Computerized stability management system
- ICH stability storage conditions
- Climatic zones I-IV + customized conditions available, including low RH conditions
- Photostability (options 1 & 2)
- Freeze/thaw cycling studies