Certified reference materials of antibacterial substances: principle of development
https://doi.org/10.20915/2687-0886-2020-16-4-27-38
Abstract
The authors of the publication have described the basic principles of the procedure of defining metrological characteristics of certified reference materials (hereinafter referred to as CRMs) of antibacterial substances that are being developed. CRMs of antibacterial substances are intended for certification of measurement procedures and accuracy control of measurement results. CRMs can be used for graduation, calibration of measuring instruments if their metrological and technical characteristics comply with the procedures of graduation and calibration of measuring instruments, as well as determination of antibiotic sensitivity of pathogenic microorganisms and authenticity of active substances in pharmaceutical drugs.
About the Authors
A. Yu. Gulyaeva
The Russian State Center for Animal Feed and Drug Standardization and Quality (VGNKI)
Russian Federation
Russian Federation
Anastasia Yu. Gulyaeva – PhD (Biol.), Deputy Head of the Department for Pharmaceutical Medicines Safety Control (VGNKI), 5 Zvenigorodskoye highway, Moscow, 123022, Russian Federation
I. V. Kis
The Russian State Center for Animal Feed and Drug Standardization and Quality (VGNKI)
Russian Federation
Russian Federation
Irina V. Kis – PhD (Biol.), Head of the Department for Pharmaceutical Medicines Safety Control (VGNKI), 5 Zvenigorodskoye highway, Moscow, 123022, Russian Federation
S. V. Kolyachkina
The Russian State Center for Animal Feed and Drug Standardization and Quality (VGNKI)
Russian Federation
Russian Federation
Svetlana V. Kolyachkina – PhD (Chem.), Deputy Head of the Department for Pharmaceutical Medicines Safety Control (VGNKI), 5 Zvenigorodskoye highway, Moscow, 123022, Russian Federation
A. Y. Khrushchev
The Russian State Center for Animal Feed and Drug Standardization and Quality (VGNKI)
Russian Federation
Russian Federation
Alexei Y. Khrushchev – PhD (Chem.), leading researcher, laboratory for quality control of medicines, Department for Pharmaceutical Medicines Safety Control (VGNKI), Researcher ID: AAD-5363–2019, 5 Zvenigorodskoye highway, Moscow, 123022, Russian Federation
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Review
For citations:
Gulyaeva A.Yu., Kis I.V., Kolyachkina S.V., Khrushchev A.Y. Certified reference materials of antibacterial substances: principle of development. Measurement Standards. Reference Materials. 2020;16(4):27-38. (In Russ.) https://doi.org/10.20915/2687-0886-2020-16-4-27-38
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