Patheon offers the full breadth of advanced analytical technologies for support of early-stage formulation for clinical trial materials. By maximizing the efficiency and flexibility for analytical and formulation development in a non-GMP environment, we are able to quickly establish a solid foundation for your product development. Our analytical development also includes:
- IND Phase-appropriate method validation
- 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 using UPLC and HPLC (including forced degradation studies)
- Related substances, chiral purity, residual solvents analysis
- Dissolution testing
- Preservative assays
- Physical methods (laser diffraction, Karl Fisher water determination)
- Nasal spray characterization (droplet size, spray pattern, spray content uniformity)
Case Study: Reliable Analytical Method Development and Validation
The Challenge A medium-size pharmaceutical company approached Patheon to develop and validate a method for quantification of several potential genotoxic impurities (GTIs) in their drug substance. The customer’s procedure, which included a derivatization step prior to analysis, suffered from variable recovery.
The Solution After reviewing the technical information and chemical structures, Patheon recommended a direct method based on LC/MS. A triple quadrupole LC/MS/MS procedure based on multiple reaction monitoring of parent/fragment ion pairs offered the high speed and sensitivity required for this method.
The Outcome Patheon’s method was successfully validated over a range of 1 to 21 ng/mL for six potential GTIs with good linearity (r ≥ 0.99) and recovery (94 to 112%).