phyproof® reference substances
phyproof® reference substances have been qualified at the level of primary reference substances as defined by the European Pharmacopoeia and other international institutions. They feature a defined absolute content. This value is based on chromatographic purity, water content, and residual-solvent and inorganic-materials levels. The accompanying documents include a comprehensive certificate of analysis, a detailed technical data sheet, and the required safety data sheet.
A special feature of phyproof®: each package is labeled with the exact substance weight down to two decimal places. This enables you to immediately produce stock solutions at defined concentrations without losses and without having to reweigh the reference substance first.
Our webshop enables you to conveniently order over 1,500 phyproof® reference substances. In addition, comprehensive information on each substance, corresponding safety data sheets, and certificates of analysis for the current batches are also available. The phyproof® Team is working continuously to expand the range of available substances. When selecting new reference substances, we give due consideration to your specifications while taking a proactive approach to current market demands and regulatory requirements. A complete overview of our current reference substance portfolio can be found here.
Primary standard documentation for marketing authorizations
We compile comprehensive primary standard documentation for all phyproof® reference substances to provide proof of quality for the regulatory dossier in compliance with the relevant guidelines (CTD module 3.2.S.5/3.2.P.6).
The documentation includes all raw data from identity and potency testing: 1H-NMR and 13C-NMR spectroscopy, mass spectrometry, infrared spectroscopy, elemental analysis, thin-layer chromatography, tests for water, residual solvents, and inorganic impurities, and purity testing using two independent, chromatographic methods. We also provide the required interpretation of the results, the validation data for both chromatographic methods, and the bibliography of cited scientific literature.
If we do not currently offer a plant-based substance, we can check its availability in collaboration with our global partners, isolate the required substance for you, and even synthesize it, where necessary.
In addition, we can support you in the identification and characterization of marker substances in your raw materials or extracts.
PhytoLab can also characterize and qualify your existing reference substances, from identification to purity testing using a chromatographic method to complete primary standard documentation.
The right technique for every situation
At PhytoLab, we use NMR, MS, FT-IR, UV-Vis, and TLC methods to identify substances. We conduct assays and purity testing using HPLC, HPTLC, and GC techniques, as well as UV-Vis measurements or titrations. Our analytical services also include elemental analysis and testing for water (Karl Fischer tests), residual solvents (headspace GC), and inorganic impurities (ICP-MS).