Analytical Method Development & Validation

Patheon is the most rapid and cost-effective way to go from molecule to market by integrating analytical method development and validation into a program driven by expertise.

Patheon offers the full breadth of advanced technologies for the analytical method development and validation in support of drug product development leading to NDA and ANDA submissions.

Our analytical services include:

• Method Validation in accordance with ICH Q2 and USP requirements
• Protocol driven stability studies

By having analytical method development and validation seamlessly integrated into a complete development program driven by an experienced dedicated team, Patheon is the most rapid and cost-effective way to go from molecule to market.

Method Development and Validation Studies

• Cleaning residual assays
• Stability indicating assays by UPLC, HPLC, and GC (including forced degradation studies)
• Related substances, chiral purity, residual solvents determinations
• Dissolution testing
• Preservative assays
• Physical methods (laser diffraction, Karl Fisher)
• Nasal spray characterization (droplet size, spray pattern, spray content uniformity)