Schedule of Services Phytax Ltd
Phytax performs analyses in the following areas:
- Identity of plant material and other natural products
- Quantitative determination of content
- Purity tests
- Toxicological assessments and risk analysis
- Safety Data Sheets
Analyses are performed according to all regulatory requirements, particularly the pharmacopoeia of Europe, China, Taiwan, Japan and the US, as well as the country-specific requirements for food regulations.
Botanical identity of plant material regardless of its origin or form.
Since its establishment in 1998, Phytax has developed a great expertise in the botanical identification of plant material from China, which in the 1980s, first came in the form of dried plant parts (roots, leaves, fruits, seeds, wood...) and a little later also as dry and liquid extracts. All of these forms are used by German-speaking doctors and therapists of Traditional Chinese medicine (TCM). To complicate matters further, many of these medicinal forms are also pre-treated, for example by boiling, roasting or, sometimes with the addition of agents such as vinegar, rice wine, honey, ginger juice or certain minerals. Such pre-treatments further complicate the analyses.
The herbs from China originate either from wild collection or from cultivated stock, resulting in highly variable products. Thus falsifications, either deliberate or otherwise were and still are, not uncommon.
Phytax has developed in-house herbal monographs whose enriched detail frequently goes beyond that of the often inadequate, standard pharmacopoeia descriptions of certain countries.
Today Phytax has thousands of reference plants, sample extracts, microtome sections, thin layer chromatograms, HPLC and FT-IR spectra, a comprehensive library of technical literature, especially highly specialized original Chinese literature, and thanks to a sophisticated, specially-created database, the ability to cross-reference and evaluate tens of thousands of analytical results. In special cases, molecular biological methods (gene sequencing) can also be applied.
More and more often authorities require quantitative assessment of the characteristic contents of the product or of the medicinally active ingredient. This is also true for toxicological assessments.
Heavy metals, pesticide residues, aflatoxins and other mycotoxins, microbial contamination and other environmental toxins in food and medicinal herbs are not allowed to exceed officially specified limits. Currently sample testing for over 600 pesticides is possible, with the range of available measurements paralleling the development of products within the chemical industry. Requirements of the European Pharmacopoeia and the Regulation (EC) No. 396/2005) and other relevant provisions are taken into account.
Naturally Phytax is also competent in the performance of classical, but nevertheless still useful analyses such as the assessment of water, extractives, acid-insoluble ash, loss on drying, bitterness value, swelling index, colour intensity etc.
Our Product – Certificate of Analysis
A Phytax Certificate of Analysis, created according to the individual needs of our customers, is almost universally valid because Phytax is:
- a Swissmedic (Swiss Agency for Therapeutic Products) approved company and entitled to perform above-mentioned tests on drugs
- GMP certified
- has a qualification system in accordance with ISO 9001: 2000
- and is authorized via a MRA (Mutual Recognition Agreement) to conduct valid analyses for a number of States
Certificates from Phytax are:
- recognised in Switzerland, the EU, EFTA, in the EWR-member states, in Japan, Australia, Canada and the USA
- conform to the Swiss legislation and the German and Austrian Pharmacists Operating Procedure (ApBetrO §§ 6 + 11, or ABO 2005 §§ 5-7)