primary standards

Our primary reference standards are comprehensively qualified:

  • Proof of identity using interpreted spectra, e.g. 1H-NMR, 13C-NMR, MS, UV, IR
  • Referencing of spectroscopic data with scientific literature
  • Assay using two independent, validated methods, e.g. chromatographic purity and quantitative NMR spectroscopy
  • Residual solvents
  • Water content according to Karl-Fischer
  • Residue on ignition or ICP-MS for determination of inorganic impurities, if necessary
  • Elemental analysis, if necessary
  • Further individual, substance-specific test parameters

The primary reference standard dossier includes all results of analytical tests and validations and can directly be incorporated into CTD-modules 3.2.S.5 or 3.2.P.6.

Contact: Simone Schäfer, Sales Reference Standard Services
Email: s.schaefer@hwi-group.de
Phone: +49 7272 7767-16

 

We use cookies to optimise the design of our websites. By continuing your visit on the website, you consent to the use of cookies. Find out more about our cookies and how we use them.

OK