The basis for all inspection certificates are
- for microbiology the requirements of Ph. Eur. 5.1.8 Cat. A,
- for heavy metals the requirements according to Ph. Eur.2.2.23,
- for pesticides the requirements of Ph. Eur. 2.8.13 and
- for aflatoxins the aflatoxin prohibition-V. of July 19, 2000,
- for testing the identity of TCM drugs (non-GMP) the microscopic, macroscopic and organoleptic test according to the Chin. Pharmacopoeia of the People’s Republic of China Engl. Edition Vol. 1, 2010,
- for the DC and HPLC fingerprint comparison the newly created analytical monographs (English) in Chromatographic Fingerprint Analysis of Herbal Medicine (Hildebert Wagner, Rudolf Bauer, Dieter Melchart, Pei-Gen Xiao, Anton Staudinger), published by Springer Verlag, Vol. I – IV, 1995-2016.
Each drug monograph contains methods for DC and HPLC fingerprint analysis including color images of the DC and graphics of HPLC, additional information on microscopy, use in TCM, use in western medicine, main ingredients of the drugs and formulas with references to all content.
In the case of TCM drugs for which there are still no test regulations for the DC-HPLC identity fingerprint analysis, these are newly created ad hoc by the Munich test institute.
The Chinese pharmacopoeia content requirements for single substances of TCM drugs are regulations for marker compounds that are not relevant for identity or effectiveness. Therefore, today they are replaced by modern methods (DC + HPLC or HPLC / MS fingerprint analysis).