Merck provides also custom made Drug Delivery Compoundsin GMP quality to the pharmaceutical industry for use in clinical trial and commercial product applications.
Activated PEG Lipids
Linkers & Activators
Improvement of an existing process
Synthesis of By-Products
Development of Analytical Methods
Sourcing of suitable Raw Materials
Validation of Analytical Methods
Small Scale Production
Process Transfer to Full Scale Production
Preparation of CTD for DMF or CMC section
Our services include the development and validation of analytical methods. We identify by-products and determine polymorphic product forms. '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