Drug Release & Stability Testing

When you're this close to bringing your product to market, Patheon's reliability is a valuable asset. What's more, we will conduct these tests for you at multiple sites – redundancy that can shield you from any risk.

Patheon gives you access to a broad range of technologies for in-process and release testing, as well as stability studies, in support of NDA and ANDA registration activities. With the experience of hundreds of projects, we have the expertise to produce the data necessary to get your project through scale-up and on to commercial production 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 manufacturing. By being able to share the same data, and easily coordinate planning and scheduling, our team can deliver maximum efficiency and on-time performance.

Release tests at Patheon include:

• ID (HPLC, TLC, UV, FTIR)
• Physical testing: LOD, Appearance, Color, Weight variation, Viscometry, Deliverable Volume
• Particle size by laser diffraction (wet and dry sampling)
• Wet chemistry tests (USP, EP, JP)
• Assay (UPLC, HPLC, GC) and related substances
• Anti-oxidant/Preservative assay
• Chiral analysis
• Content and Blend Uniformity
• Residual solvents (OVI)
• KF (Volumetric, Coulometric),
• Dissolution: Immediate Release, Enteric Coated, Delayed Release, Extended Release and Pulsatile Delivery – USP Apparatus I & II (1- and 2-stage dissolution profiles), III, IV and VII
• Abuse deterrent testing, including alcohol dose-dumping
• Metal content (ICP, AA)
• Microbial testing (MLT, MET, sterility)
• Preservative efficacy test

Patheon is rock solid. We're not going anywhere. This is important because stability testing can include long-term studies that require storage and testing for up to five years. When you're this close to bringing your product to market, Patheon's reliability is a valuable asset. What's more, we will conduct these tests for you at multiple sites – redundancy that can shield you from any risk. Patheon has such a great reputation that we are who companies turn to when another vendor can't complete their study. In these situations, we have been able to make a rapid transfer mid study without interruption, saving the customer valuable time.

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