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Botanik Buch

In Detail

Botanical Identity

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). Complicating matters further, is that 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 naturally add certain challenges to the analyses of such products.
Additionally, Chinese herbs are either wild-sourced or cultivated, which leads to highly variable products and the possibility of misidentification. Adulterants, 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 boasts a collection of over 10,000 reference products, sample extracts, microtome sections, thin layer chromatograms, HPLC and FT-IR spectra, a comprehensive library of technical literature, especially highly specialised original Chinese texts, and thanks to a sophisticated, custombuilt 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.

Assays

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.

Essential to the effectiveness of a medicinal remedy or product is the content of a particular active ingredient (e.g., Ephedrine) or the presence of certain characteristic elements such as essential oils (e.g., peppermint oil). Likewise, the presence of toxins such as pyrrolizidine alkaloids can place the consumer at risk. For these reasons the quantity of such substances is highly regulated through government agencies.

Tests

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. Analyses take into account the requirements of the European Pharmacopoeia (Regulation EG No. 396/2005) and other relevant specifications.

Classical Tests

In compliance with Pharmacopoeia, other tests must also be performed such as the assessment of foreign matter, water, extractives, acid-insoluble ash, loss on drying, bitterness value, swelling index, and colour intensity.

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)