Herbal products contain herbs/extracts consisting of a large number of chemical constituents of which only a few may be characterized. Furthermore, in most cases the constituents responsible for the therapeutic activity are unknown or only partly explained or are present in un-measurable quantities. In such cases other constituents that may not have therapeutic values may be quantified. Such constituents can thus serve as "biomarkers". Markers serve to calculate the quantity of herbal substance(s) or herbal preparation(s) in the Herbal Medicinal product if that marker has been quantitatively determined in the herbal substance(s) or herbal preparation(s) themselves.
In herbal medicinal products containing combinations of herbal substances and/or herbal preparations, quality control may be more problematic because other herbal substances and/or preparations may interfere with the analysis, e.g. extraction or detection of a marker may be affected by other herbal substances present (co-elution) in the finished product. In any case the quality of a combination herbal medicinal product should in general be guaranteed and demonstrated in accordance with the existing guidance. We work with you to characterize your product and validate the quality thereof. Our capabilities include the following;
Our team has expertise in isolation, purification and identification of natural products with help of advanced analytical and chromatographic techniques. in a typical experiment we process both the aqueous as well as non-aqueous extracts of plants, identify and profile the major known phytochemicals. We could also provide marker compounds, major phytoconstituents or enriched extracts of plants in large quantities for various needs as per customer request.
standardization is the most essential part for any formulation in order to achieve the batch to batch quality consistency. However, As mentioned above it is particularly challenging for the herbal products. We use either in-house standards for some herbals, or procure standard markers from the market, or use sponsor provided markers for their products. We then develop the method of identification for a standards using modern analytical techniques. Our team is extensively trained in method development and validation. After rigorous validation, we can identify and quantify the herb in your products. Our team can carry out Complete standardization right from raw material to finished herbal formulation.