Development and Validation
Our services include the development and validation of analytical methods. We identify by-products and determine polymorphic product forms. MilliporeSigma’s broad portfolio of analytical methods includes HPLC(-MS), CE, GC(-MS), FT-IR, NMR, XRD, DSC, ICP, particle size determination, and many more.
Additionally, we routinely perform microbiological tests, quantify bioburden and endotoxin contents and perform stability studies according to ICH guidelines.
- Chemical Analytical Testing
- Development and Validation of Analytical Methods
- Identification of By-Products
- Determination of Polymorphic Form
- Stability Studies according to ICH
- Determination of Bioburden and Endotoxin Content
- Development and Validation of Microbiological Methods
- HPLC (/MS)
- GC (/MS)
- Karl Fischer
- Particle Size Determination
- Disintegration Test on Drug Products
- LAL Endotoxin Test