Drug Product Testing
With 55+ years of experience, our expert teams typically develop 1,000+ analytical methods and validate 250+ methods annually. Drawing upon our vast pool of scientific knowledge, we greatly reduce the analytical challenges that typically arise during drug development.
We offer a full suite of analytical testing for a range of different product types including small molecules, peptides, biologics, conjugates, highly potent and controlled substances.
Analytical testing not only ensures that drugs are safe, effective and high quality, it also optimizes drug absorption and enhances therapeutic impact.
Pre-formulation
After formulation prototypes are developed, we conduct analytical methods to assess the following:
- Particle Size Analysis
- XRPD (X-Ray Powder Diffraction)
- Bulk Density
- Impurity Analysis
- DSC/TGA (Differential Scanning Calorimetry) / (Thermogravimetric Analysis)
Process Development & Formulation Development
Further tests are conducted as formulation and process development progresses. Our integrated analytical strategy includes the methods below to further investigate the drug product’s efficacy and shelf-life.
- Particle Size Analysis
- XRPD (X-Ray Powder Diffraction)
- Bulk Density
- Impurity Analysis
- DSC/TGA (Differential Scanning Calorimetry) / (Thermogravimetric Analysis)
- Stability Testing
- Shear cell
- Dissolution