Characteristics of Assessments of the Sterility of Various Groups of Solid Drug Formulations for Parenteral Administration
- Авторлар: Gunar O.1, Sakhno N.1, Roshchina M.1
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Мекемелер:
- National Center for Expert Evaluation of Medicinal Products, Russian Ministry of Health
- Шығарылым: Том 50, № 1 (2016)
- Беттер: 47-51
- Бөлім: 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
Дәйексөз келтіру
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.
Негізгі сөздер
Авторлар туралы
O. Gunar
National Center for Expert Evaluation of Medicinal Products, Russian Ministry of Health
Хат алмасуға жауапты Автор.
Email: gunar@expmed.ru
Ресей, 8 Petrovskii Boulevard, Moscow, 127051
N. Sakhno
National Center for Expert Evaluation of Medicinal Products, Russian Ministry of Health
Email: gunar@expmed.ru
Ресей, 8 Petrovskii Boulevard, Moscow, 127051
M. Roshchina
National Center for Expert Evaluation of Medicinal Products, Russian Ministry of Health
Email: gunar@expmed.ru
Ресей, 8 Petrovskii Boulevard, Moscow, 127051