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Title of Journal: Pharm Chem J

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Abbravation: Pharmaceutical Chemistry Journal

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Springer US

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DOI

10.1002/chin.200628211

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1573-9031

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Characteristics of Assessments of the Sterility of

Authors: O V Gunar N G Sakhno M V Roshchina
Publish Date: 2016/05/10
Volume: 50, Issue: 1, Pages: 47-51
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Abstract

We present an informationanalytical 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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