Structural Identity & Molecular Characterisation Spectroscopy & Chromatography
- ¹H NMR spectroscopy (≥500 MHz) for structural fingerprinting and identity confirmation
- 2D NMR techniques (where required) for advanced structural interrogation
- Chromatographic identity testing (HPLC/UHPLC)
- LC-MS / HRMS profiling of intact polysaccharides and derived oligosaccharides
- Disaccharide compositional analysis following enzymatic depolymerisation
- Multidetector SEC/GPC for molecular weight distribution and absolute Mw assessment
Functional & Potency Assessment Functional assays
- Anti-factor IIa activity assays
- Anti-factor Xa activity assays
- Anti-Xa : IIa ratio determination
- Clotting-based assays (e.g., APTT-based methods) where appropriate
- Comparative functional profiling across batches or sources
Impurity & Adulterant Profiling Targeted assays
- Oversulfated chondroitin sulfate (OSCS) screening
- Dermatan sulfate / galactosamine impurity assessment
- Nucleotidic impurities (UV 260 nm and MS-based approaches)
- Protein and residual biomolecule impurities
- Investigational profiling of atypical or unexpected structural features
Physicochemical & Safety Testing Core QC
- pH determination
- Loss on drying / moisture content
- Residue on ignition
- Nitrogen content and elemental analysis (including heavy metals where required)
- Bacterial endotoxins (LAL)
- Sterility testing (where applicable)
Scope: Studies can be delivered as discrete analytical packages or as part of an integrated
programme. Reporting can be tailored for research, quality assessment, comparability and regulatory-focused
investigations, as required.
Enquiries:
enquiries@tkbio.co.uk