The development of microbiological methods for drug analysis
Abstract
The article presents the review of the national regulatory documents on drug testing for microbiological characteristics, such as «Sterility», «Microbiological Purity» etc. It discusses the history of the establishment of characteristics and the elaboration of the related general pharmacopoeia monographs, as well as prospects for the development of methods in connection with the publication of the Russian State Pharmacopoeia XIII edition. There is a clear trend towards harmonization with the leading world pharmacopoeias, but the Russian State Pharmacopoeia maintains the individual characteristics of drug quality analysis in terms of microbiological characteristics, including the introduction of new technologies, process automation and taking into account the special features of individual drug groups.
Keywords
микробиологические показатели,
стерильность,
микробиологическая чистота,
содержание витаминов,
концентрация микробных клеток,
эффективность консервантов,
microbiological characteristics,
sterility,
microbiological purity,
vitamin content,
concentration of microbial cells,
preservative effectiveness
About the Authors
O. V. Gunar
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
N. G. Sakhno
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
E. S. Novik
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
G. M. Bulgakova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
L. V. Kolosova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
I. A. Buylova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
M. V. Roshchina
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
References
1. Bugno A, de Jesus Andreoli Pinto T. The influence of incubation conditions in sterility test. PDA Journal of pharmaceutical science and technology 2003; 57(6): 399–403.
2. State Pharmacopoeia of the USSR. 11th ed. Issue 2. Moscow: Meditsina; 1990 (in Russian).
3. State Pharmacopoeia of the Russian Federation. 12th ed. Part 1. Moscow: NCESMP; 2007 (in Russian).
4. General Monograph 42-0016–04. Methods of microbiological control of medicinal plant resources, consisting of one or more kinds of raw materials (charges) – packaged products as well as vegetable raw materials in bulk. Moscow; 2004 (in Russian).
Review
For citations:
Gunar O.V., Sakhno N.G., Novik E.S., Bulgakova G.M., Kolosova L.V., Buylova I.A., Roshchina M.V. The development of microbiological methods for drug analysis. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2016;(1):15-18. (In Russ.)
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