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Primary standard documentation for marketing authorisation dossiers

With PhytoLab to marketing authorisation: For all phyproof reference substances, we also produce extensive primary standard documentation which provides comprehensive proof of the quality of the reference substances used for your documentation, and fulfils all the requirements according to Appendix 6 of the “Notice concerning the approval of pharmaceuticals from the Federal Institute for Drugs and Medical Devices” dated 31.10.1996. Our primary standard documentations, which you can incorporate directly into your documentation (CTD module 3.2.S.5/3.2.P.6), have been recognised by authorities for many years.

Extensive, because it is comprehensive

The phyproof primary standard documentation contains all the analytical raw data from the identity and content tests: 1H-NMR and 13C-NMR spectroscopy, mass spectrometry, infrared spectroscopy, elemental analysis, thin-layer chromatography, testing for water, residual solvents and inorganic impurities, as well as chromatographic purity testing using two independent methods. We also provide the necessary interpretation of the results, validation data for the two chromatography methods, and the bibliography for the scientific literature that has been used.