Additional Services

Primary standard documentation for marketing authorizations

We compile comprehensive primary standard documentation dossiers for all phyproof^® reference substances to provide proof of quality for regulatory dossiers in compliance with the relevant guidelines (CTD module 3.2.S.5 / 3.2.P.6). These documentations includes all raw data from identity and purity testing:

• 1H-NMR and 13C-NMR spectroscopy
• mass spectrometry (e.g. HPLC-MS/MS, GC-MS or HR-MS)
• infrared spectroscopy
• elemental analysis (CHNO)
• thin-layer chromatography
• content of water (coulometric Karl Fischer titration)
• residual solvents (headspace GC)
• inorganic impurities (ICP-MS)
• chromatographic purity by using two independent methods

We also provide the required interpretation of all results, the validation data for both chromatographic methods, and the bibliography of cited scientific literature.

Sourcing and custom isolations

Even if we do not currently offer a certain herbal reference substance that you are looking for we can frequently source it through our international network of partners and characterize it to the desired extent. Alternatively, we do also perform custom isolation or synthesis projects, if desired also on an exclusive and confidential basis. Contact us to discuss your needs.