Стандартизация Фармацевтических Субстанций По Разделу «Чистота»

Олефир, Ю. В.; Саканян, Елена Ивановна; Шемерянкина, Т. Б.; Сенченко, С. П.; Зайцев, С. А.; Бармин, А. В.

doi:10.30906/0023-1134-2018-52-8-56-60

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“…Совершенствование требований к стандартизации фармацевтических субстанций (далее -субстанций) и контроль их качества позволяют обеспечить производство эффективных и безопасных готовых лекарственных средств [1][2][3][4][5][6][7].…”

Section: обзоры / Reviewsunclassified

“…Государственная фармакопея Российской Федерации (ГФ РФ) является гарантом качества лекарственных средств, начиная от фармацевтической разработки до их реализации [8], посредством предоставления соответствующих стандартизованных процедур для анализа лекарственных средств 1 . В настоящее время в обращении на фармацевтическом рынке Российской Федерации находится около 1000 субстанций химического происхождения различных наименований [9,10].…”

Section: обзоры / Reviewsunclassified

“…Важным требованием к качеству субстанций является их чистота. Контроль чистоты предусматривает оценку химических примесей (органических, неорганических, остаточных растворителей) и микробной контаминации [1,4]. Для этого в ГФ РФ предусмотрено большое количество показателей и методов, используемых для их определения.…”

Section: обзоры / Reviewsunclassified

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Nonspecific Impurities in Pharmaceutical Substances: Characteristics of Test Methods

Биглова¹,

Гадасина²,

Bokovikova³

et al. 2019

Vedomosti Nauchnogo tsentra ekspertizy sredstv meditsinskogo pr

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One of the prerequisites of efficacy and safety of finished pharmaceutical products is the quality of pharmaceutical substances used in their production. Criteria of assessment of pharmaceutical substance purity are determined by the substance composition and production technology, as well as by specific aspects of the finished pharmaceutical product production and use. It is necessary to control the content of nonspecific organic and inorganic impurities, impurities of microbial origin, and residual solvents. The aim of the study was to analyse characteristics of test methods used to determine nonspecific impurities in pharmaceutical substances. The State Pharmacopoeia of the Russian Federation describes various chemical, physical, physicochemical and biological tests for the analysis of nonspecific impurities. Determination of inorganic cations and anions usually includes comparison of test solutions with solutions of the corresponding reference standards, or checking the absence of a positive reaction in the test solution. Quantitative analysis of trace impurities largely relies on highly specific and sensitive test methods, such as atomic absorption spectrometry, atomic emission spectrometry and inductively coupled plasma mass spectrometry. The content of residual organic solvents is determined by gas chromatography or high-performance liquid chromatography. The purity and safety of pharmaceutical substances are ensured by biological tests: “Microbial quality”, “Sterility”, “Pyrogenicity”, “Bacterial endotoxins”. Specific characteristics of test methods used for determination of the content of nonspecific impurities in various pharmaceutical substances depend on physicochemical properties of the tested substances, toxicity of the analysed impurities, and content limits. The results of the study make it possible to formulate a methodological approach to the development of criteria for assessing the quality of pharmaceutical substances. This approach includes mandatory compliance with the basic principles of substance standardisation, as well as case-by-case selection of quality parameters, specific test conditions and content limits for impurities.

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Section: обзоры / Reviewsunclassified