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
Phone: +49 7272 7767-16


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