Analytical Services

Syntagon’s analytical chemistry department supports process development and manufacturing with analytical methods, specifications, quality control and characterization. Whether your sample is a drug substance, drug product or biological sample (e.g urine or plasma), we can construct a method of analysis uniquely suited to your objectives and deadlines. In addition to this, we develop stand-alone analytical services for industries outside biotechnology and pharmaceuticals such as petrochemicals and cosmetics.

For the analysis of drug substances, we support process development and GMP manufacturing with analytical methods for raw materials, process controls, intermediates and end products.


Our analytical chemistry department also performs:

  • Drafting of raw material, intermediate and end-product specifications
  • Quality control
  • ICH stability and forced degradation studies
  • Analytical method validation
  • Characterization of analytical reference standards
  • Structure elucidation of unknown impurities
  • Method development for PGIs and other process impurities
  • Method development for preparative HPLC

Analysis of drug products

Methods for testing and determining degradation products are regularly developed at Syntagon in order to assist drug product development. ICH stability studies and structure elucidation of unknown impurities can also be performed in accordance with your needs.


Analytical Chemistry for the CMC component of IMPD/IND

We also perform analysis of physical and chemical characterization for the CMC component of IMPD/IND documentation. In addition, we support clients by drafting written material for IMPD/IND documentation.


What we deliver: Documented proof structure, purity and all other quality data required from a scientific and regulatory standpoint.