Study of heavy metal and arsenic impurities in biologically active additives

In the assortment of pharmaceutical organizations, along with registered medicinal products (MP), there is a fairly large number of biologically active additives (BAA). In connection with the huge growth rate of the number of dietary supplements in the pharmaceutical market, testing their quality, efficacy, safety and the development of new research methods in this area is of particular importance. Objective: to determine the content of inorganic impurities (lead, cadmium, arsenic, mercury) in the selected objects. As a result of studying the assortment of dietary supplements, as well as regulatory documentation, the following objects were selected for the study: Mumie Altai "Balsam of mountains", tablets, manufacturer - LLC "Farm-product", Russia, Barnaul, dietary supplement for food - a source of humic acids, not being a medicine, were obtained through the pharmacy network. Spirulina VEL®, tablets, manufactured by LLC - "V-MIN", Russia, Moscow region, Sergiev Posad, dietary supplement for food - a source of phycocyanins and beta-carotene, not being a medicine, were obtained through the pharmacy network. Materials and methods. For the determination of lead, cadmium and arsenic, the method of atomic absorption spectrometry was chosen by measuring the absorption of radiation at a certain wavelength corresponding to the element to be determined. To determine mercury, we used an extraction-photometric method based on the formation of a complex compound of mercury (II) -ion with dithizone and measurement of the degree of absorption of non-monochromatic light by the formed complex. Results. The content of lead-ion, cadmium-ion and mercury-ion does not exceed the maximum permissible levels for both samples in accordance with the requirements of both the Technical Regulations and XIV State Pharmacopeia, while the content of arsenic exceeds for the Mumie sample in accordance with the requirements of XIV State Pharmacopeia, but does not exceed according to the requirements of TR CU 021/2011. Conclusion. It was found that the content of heavy metals and arsenic does not exceed the permissible level in accordance with the requirements of the Technological Regulations of the Customs Union 021/2011 for both samples. If we compare with the requirements of General Pharmacopoeia Monograph 1.5.3.0009.15 XIV State Pharmacopeia, then there is an excess in the permissible level of arsenic in the Mumie sample.

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