Characteristics of Assessments of the Sterility of Various Groups of Solid Drug Formulations for Parenteral Administration
- Authors: Gunar O.V.1, Sakhno N.G.1, Roshchina M.V.1
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Affiliations:
- National Center for Expert Evaluation of Medicinal Products, Russian Ministry of Health
- Issue: Vol 50, No 1 (2016)
- Pages: 47-51
- Section: Structure of Chemical Compounds, Methods of Analysis and Process Control
- URL: https://journals.rcsi.science/0091-150X/article/view/244318
- DOI: https://doi.org/10.1007/s11094-016-1397-y
- ID: 244318
Cite item
Abstract
We present an information-analytical review of methods for evaluating the sterility of solid drug formulations. Current normative documentation regulating the quality of parenteral drugs is analyzed and the main limitations of the test method for this indicator are described. The probability of detecting microorganisms depending on the proportion of contaminated units in a batch and the quantity of sample taken for analysis is assessed. Results obtained from analysis of the State Register of Drugs relating to the nomenclature of drugs in solid formulations and their areas of use are presented. The characteristics of tests for individual pharmacological groups of drugs are described.
About the authors
O. V. Gunar
National Center for Expert Evaluation of Medicinal Products, Russian Ministry of Health
Author for correspondence.
Email: gunar@expmed.ru
Russian Federation, 8 Petrovskii Boulevard, Moscow, 127051
N. G. Sakhno
National Center for Expert Evaluation of Medicinal Products, Russian Ministry of Health
Email: gunar@expmed.ru
Russian Federation, 8 Petrovskii Boulevard, Moscow, 127051
M. V. Roshchina
National Center for Expert Evaluation of Medicinal Products, Russian Ministry of Health
Email: gunar@expmed.ru
Russian Federation, 8 Petrovskii Boulevard, Moscow, 127051