Characteristics of Assessments of the Sterility of Various Groups of Solid Drug Formulations for Parenteral Administration
- Авторы: Gunar O.1, Sakhno N.1, Roshchina M.1
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Учреждения:
- National Center for Expert Evaluation of Medicinal Products, Russian Ministry of Health
- Выпуск: Том 50, № 1 (2016)
- Страницы: 47-51
- Раздел: 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
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Аннотация
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.
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Об авторах
O. Gunar
National Center for Expert Evaluation of Medicinal Products, Russian Ministry of Health
Автор, ответственный за переписку.
Email: gunar@expmed.ru
Россия, 8 Petrovskii Boulevard, Moscow, 127051
N. Sakhno
National Center for Expert Evaluation of Medicinal Products, Russian Ministry of Health
Email: gunar@expmed.ru
Россия, 8 Petrovskii Boulevard, Moscow, 127051
M. Roshchina
National Center for Expert Evaluation of Medicinal Products, Russian Ministry of Health
Email: gunar@expmed.ru
Россия, 8 Petrovskii Boulevard, Moscow, 127051