Comparative Analysis of Pharmacopoeia Requirements to Medicinal Plant Raw Materials of the Genus Iris L.

A BSTRACT In the context of globalization and the growth of the pharmaceutical market, drug quality control and standardization are becoming strategic directions for the pharmaceutical industry’s development. Analyzing the requirements of international pharmacopoeias allows us to develop unified quality indicators for drugs. A comparative analysis of the pharmacopoeial requirements of various countries was carried out to develop a normative document regulating the quality of medicinal plant materials of plants of the genus Iris L. The analysis revealed that monographs on medicinal plant materials of plants of the genus Iris are found in the European Pharmacopoeia (8.0, 2013), the French Pharmacopoeia (11, 2012), the Pharmacopoeia of Ukraine (2.1., 2016), the Pharmacopoeia of China (2005), as well as in the State Pharmacopoeia of the USSR (VIII edition). Furthermore, monographs on plants of the genus Iris are found in several homeopathic pharmacopoeias: the Homeopathic Pharmacopoeia of India, the American Homeopathic Pharmacopoeia, the British Homeopathic Pharmacopoeia, the German Homeopathic Pharmacopoeia, the Taiwan Herbal Pharmacopoeia, as well as in the supplements to the British Pharmacopoeia in the British Pharmaceutical Codex. A comparative analysis of pharmacopoeial monographs has established the pharmacopoeial level of quality and safety requirements for medicinal plant materials of plants of the genus Iris . The analysis has revealed the following main quality indicators for the raw materials of plants of the genus Iris : determination and identification, including macroscopic and microscopic analyses, thin-layer chromatography; determination of total ash and ash insoluble in hydrochloric acid; quantitative determination of the main active substance; requirements for storage conditions and shelf life. As a result of a complete comparative analysis of the information obtained, a draft quality specification for the raw materials of the Kazakhstani Iris species Iris sogdiana and Iris ruthenica will be developed.