Categories - 2) Primary Standards
2) Primary Standards
Primary Standards of Phytochem® are Quantitative Standards
for the estimation of the absolute content and quality control. Moreover the
documentation in English with about 40 pages is done as a Reference
Substance Master File (RMF Format) fulfilling all requirements of
the authorities.
Documentation contains 4 sections of compound data:
a) Basic Compound Data
The RMF contains physical and chemical data, formulas, appearance, stability,
solubility, storage conditions, literature references and also manufacturing
procedure and last used solvent.
b) Evidence of Identity
The characteristic UV – spectrum is compared with the online UV –
spectrum and the following Identity tests are also done:
IR – spectrum, Mass – spectrum, 13C NMR and 1H NMR – spectra
and melting point. All measured data are compared with literature data if
available and also with the theoretical expected data.