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Modern methods of analysis in the quality control of dietary additives

   Product testing is carried out in the QCD of the LLC "Experimental plant "GNCLS" which has 4 laboratories: laboratory of physical and chemical methods of analysis, microbiological laboratory, testing laboratory, analytical laboratory. Laboratory is certified by the State Service for Drugs and Medical Devices, SE "Kharkiv regional centre for standardization, metrology and certification." Laboratories are equipped with modern control and validated analytical equipment meeting the requirements of SPU.

     Quality control is carried out at all stages of production of drugs - from the raw material stage testing for compliance with regulatory documentation to the production and manufacture of finished products. Monitoring is conducted in accordance with the Specifications for organoleptic, physical and chemical parameters, toxic and hygienic and microbiological parameters, content of toxic elements, pesticides, radionuclides. In the TU "Methods of quality control of the products" the control procedures in accordance with methodological manuals, GOSTs, pharmacopoeia articles are provided. TU also contain requirements for raw materials, packaging, labelling, safety, environmental protection, and rules of acceptance, transport and storage.

    In addition to the mentioned methods and specifications, the methods for identification and quantification of active ingredients in accordance with requirements to medicines the assessing the quality of DR were adapted and implemented: SPU, European Pharmacopoeia, and U.S. Pharmacopeia for dietary supplements (USP Dietary Supplements Compendium). For analytical studies foreign and domestic literature is also used.

   Today, the majority of foreign pharmacopoeia monographs about drugs of plant and animal origin contain methods with the use of HPLC method. The method is characterized by high sensitivity, specificity and accuracy, under the conditions of this method it is possible to carry out qualitative and quantitative analysis of most substances of different classes of multi-component mixtures of biologically active substances, separation of substances of one group.


Extract of Ginkgo biloba. Determination of flavonoids according to USP

    Gas chromatography is used to evaluate the chromatographic profile of different types of essential oils of plants, to determine fatty acid composition of vegetable and animal fats, to determine active substances as well as excipients in the finished product.


Determination of fatty acid composition of the concentrate of sea buckthorn oil

     For identification of active components of herbal raw material and extracts, the TLC with using standard samples of active substances is used.

    Along with chromatographic methods for assessing quality of active components in herbal raw material and extracts, in monographs of leading pharmacopoeias of the world the method of spectrophotometry in UV- and visible areas of the spectrum is used. The method is quite expressive, as well as in the case of using the specific absorption index it helps avoid the use of an expensive standard sample.

   When carrying out the DR control by spectral and chromatographic methods, the pharmacopoeia standard samples and standards of the leading manufacturers of phyto-chemical and analytical standards are used.

  Thus, the primary task of "Vertex" in the field of quality control of dietary additives is the development of new and update of already approved methods of identification and quantification of the active substances in accordance with the requirements of SPU, European Pharmacopoeia to medicines and the United States Pharmacopeia for dietary additives.