Reference Standard Preparation and Characterisation
Reference Standard Preparation and Characterisation
Reference Standard Preparation and Characterisation
Using Spectroscopic Techniques for peptide reference standard preparation and peptide characterisation
A reference standard of the API can be prepared by drawing material from the GMP batch. A specification reference standard and Certificate of Analysis will be issued.
The reference standard can be characterised in a number of ways, using a number of spectroscopic techniques:
- Accurate mass determination of molecular weight by reflectron QTOF MS analysis (better than 1 ppm mass accuracy)
- Peptide sequencing by QTOF – CID – MS/MS
- Ratio of amino acids by amino acid analysis (performed to an approved Almac subcontractor)
- Chirality of amino acids to be determined by chiral LC-MS analysis after hydrolysis with DCl
- Structural elucidation by 1D and 2D NMR (will require experiments such as COSY, TOCSY, HSQC, HMBC and ROESY)
