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Know-how for new methods

Particularly for the approval of herbal medicines, individual methods have to be developed for the identification and quantification of the active substance. These must be comprehensively validated in accordance with the state of the art, particularly in accordance with the guidelines of the ICH, in order to ensure the reliability of the results. Suitable ingredients that can be used as marker substances are often present in only very small amounts. The development and validation of selective and sufficiently sensitive methods therefore require experience and first-class equipment.

Methods for practice

In the development of methods, PhytoLab clients benefit not only from our many years of experimental and analytical experience, but also from the use of modern, computer-assisted simulation of HPLC chromatographs. Through this, PhytoLab is able to optimise the chromatographic conditions quickly. The result: robust HPLC methods which can be easily adopted in routine operation. On request, method validation is carried out in accordance with the corresponding ICH guideline (CPMP/ICH/281/95 and 381/95). All raw data are recorded and archived, so that comprehensive documentation of all relevant validation data is available for a concluding report.