We offer method development, method validation and structural characterization study of many different sulfated products including low-molecular-weight heparins (LMWH) to evaluate active ingredient sameness of the generic and innovator products.
List of our services:
- Equivalence of physicochemical properties: This includes determination of molecular weight distribution by SEC-HPLC; chain mapping by CTA-SAX and LC-MS; presence of common functional groups by proton and carbon NMR spectroscopy and molar ratio of sulfate to carboxylate by conductivity titration.
- Equivalence of source material and mode of depolymerization: This study includes monosaccharide analysis by HPAEC; proton NMR and disaccharide analysis of the product.
Equivalence of disaccharide building blocks, fragment mapping and sequence of oligosaccharide species:
This study includes disaccharide building blocks analysis using exhaustive digestion by SAX-HPLC and LC-MS; fragment mapping individual enzymes; sequence of oligosaccharides by separation and 2D NMR; determination of ratio of modified sugars by 2D NMR spectroscopy.