Reference Standard Preparation and Characterisation

Using Spectroscopic Techniques to Characterise a Reference Standard

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)

 

Contact Us

Related Resources