The Assessment of the Possibility to Use the Coulter's Method (Electrosensitive Zones) for Identification of Invisible Particulate Matter in Human Blood-Derived Products Produced in Russia
Abstract
The article presents the results of the study of the possibility of using the method of electrosensitive zones (Coulter's method) to evaluate the indicator «Particulate matter (invisible)» in domestic medicinal human blood-derived products. The studies were carried out on suspensions of latex particles, the size and quantity of which corresponded to those normalized for parenteral preparations. Suspensions simulated human blood-derived products, which can presumably contain some invisible particles. Factors that can influence the reliability of test results conducted using the method of electrosensitive zones are determined: the electrical conductivity of the test sample, the volume of the analytical sample, the degree of dilution of the sample.
About the Authors
A. A. Voropaev
Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation
Russian Federation
Russian Federation
O. V. Fadeikina
Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation
Russian Federation
Russian Federation
T. N. Ermolaeva
Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation
Russian Federation
Russian Federation
D. S. Davydov
Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation
Russian Federation
Russian Federation
E. Yu. Kudasheva
Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation
Russian Federation
Russian Federation
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Review
For citations:
Voropaev A.A., Fadeikina O.V., Ermolaeva T.N., Davydov D.S., Kudasheva E.Yu. The Assessment of the Possibility to Use the Coulter's Method (Electrosensitive Zones) for Identification of Invisible Particulate Matter in Human Blood-Derived Products Produced in Russia. Antibiot Khimioter = Antibiotics and Chemotherapy. 2017;62(7-8):36-41. (In Russ.)
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