Water for injections: Global trends in pharmacopoeial quality assessment and Russian expert practice ; Вода для инъекций: мировые тренды в фармакопейной оценке качества и российская экспертная практика
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| Názov: | Water for injections: Global trends in pharmacopoeial quality assessment and Russian expert practice ; Вода для инъекций: мировые тренды в фармакопейной оценке качества и российская экспертная практика |
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| Autori: | S. M. Sukhanova, A. A. Semenov, N. M. Minaeva, С. М. Суханова, А. А. Семенов, Н. М. Минаева |
| Prispievatelia: | This study was conducted by the Scientific Centre for Expert Evaluation of Medicinal Products as part of the applied research funded under State Assignment No. 056-00001-25-00 (R&D reporting No. 124022200103-5)., Работа выполнена в рамках государственного задания ФГБУ «НЦЭСМП» Минздрава России № 056-00001-25-00 на проведение прикладных научных исследований (номер государственного учета НИР № 124022200103-5). |
| Zdroj: | Biological Products. Prevention, Diagnosis, Treatment; Том 25, № 1 (2025); 97-110 ; БИОпрепараты. Профилактика, диагностика, лечение; Том 25, № 1 (2025); 97-110 ; 2619-1156 ; 2221-996X ; 10.30895/2221-996X-2025-25-1 |
| Informácie o vydavateľovi: | Scientific Centre for Expert Evaluation of Medicinal Products |
| Rok vydania: | 2025 |
| Zbierka: | BIOpreparations. Prevention, Diagnosis, Treatment (E-Journal) / БИОпрепараты. Профилактика, диагностика, лечение |
| Predmety: | фармакопейные требования, quality assessment, conductivity, total organic carbon, impurities, pharmacopoeial requirements, оценка качества, электропроводность, общий органический углерод, примеси |
| Popis: | INTRODUCTION. High quality standards for sterilised water for injections arise from the need to guarantee the safety and effectiveness of injectable medicines, especially biologicals, since the presence of impurities in the solvent (mainly microbial contaminants, endotoxins, and heavy metals) can lead to serious adverse drug reactions. Therefore, it is important to determine the most promising approaches to assessing the quality of water for injections to develop the regulatory requirements for the Eurasian Economic Union (EAEU).AIM. This study aimed to analyse key trends in the quality assessment of water for injections used as a solvent for medicinal products.DISCUSSION. This study involved a retrospective comparison of the quality control requirements for water for injections established by the world’s major pharmacopoeias, including the State Pharmacopoeia of the Russian Federation, the United States Pharmacopeia, the Japanese Pharmacopoeia, the European Pharmacopoeia, the British Pharmacopoeia, the Pharmacopoeia, and the Pharmacopoeia of the People’s Republic of China. Additionally, the comparison included recommendations by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and the Pharmacopoeia Discussion Group. The past decade witnessed significant changes in the approach of international pharmacopoeias to the control of organic and inorganic impurities in water for injections, both in terms of analytical procedures and in terms of the number of tests required. According to the comparison, the most significant changes to the quality control requirements for sterilised water for injections in the finished dosage form were introduced by the European Pharmacopoeia in 2024. The authors considered the possibility to streamline the quality control procedure by reducing the number of tests and replacing the currently required ten qualitative tests for inorganic impurities with a single quantitative determination of electrical conductivity. This article ... |
| Druh dokumentu: | article in journal/newspaper |
| Popis súboru: | application/pdf |
| Jazyk: | Russian |
| Relation: | https://www.biopreparations.ru/jour/article/view/626/999; https://www.biopreparations.ru/jour/article/downloadSuppFile/626/1161; https://www.biopreparations.ru/jour/article/downloadSuppFile/626/1218; Матвеева ОА, Ковалева ЕЛ, Пономаренко АА. Оценка и контроль органических примесей в лекарственных средствах: обзор. Ведомости Научного центра экспертизы средств медицинского применения. Регуляторные исследования и экспертиза лекарственных средств. 2024;14(2):217–27. https://doi.org/10.30895/1991-2919-2024-14-2-217-227; Машин ВВ, Сергеев АН, Мартынова НН, Антипина ТВ, Саканян ЕИ, Катаева ВВ, Загидуллин НВ. Минимизация риска вирусной контаминации гетерологичных иммуноглобулинов в рамках требований Государственной фармакопеи Российской Федерации. БИОпрепараты. Профилактика, диагностика, лечение. 2022;22(2):112–23. https://doi.org/10.30895/2221-996X-2022-22-2-112-123; Sheinin EB. Pharmacopeial methods and tests. In: Specification of drug substances and products. Elsevier; 2020. 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| DOI: | 10.30895/2221-996X-2025-25-1-97-110 |
| Dostupnosť: | https://www.biopreparations.ru/jour/article/view/626 https://doi.org/10.30895/2221-996X-2025-25-1-97-110 |
| Rights: | Copyright NoticeAuthors who have their articles published in this journal agree to the following terms:The authors retain copyright for their work and grant the journal with the right of first publication under Creative Commons Attribution License that allows others to pass on the work provided they include references to the authors and the original publication.The authors may post preprints, postprints and research data of their articles in any institutional or public repositories in line with the journal’s Preprint and Postprint Deposition ; Авторы, публикующие статьи в данном журнале, соглашаются со следующим:Авторы сохраняют за собой авторские права на работу и предоставляют журналу право первой публикации работы на условиях не эксклюзивной лицензии Creative Commons Attribution License, которая позволяет другим распространять данную работу с обязательным сохранением ссылок на авторов оригинальной работы и оригинальную публикацию в этом журнале.Авторы имеют право размещать препринты и постпринты своих работ, а также исследовательские данные из них в институтском хранилище или публичных репозиториях, согласно политике журнала. |
| Prístupové číslo: | edsbas.D75DCB9D |
| Databáza: | BASE |
Nájsť tento článok vo Web of Science | Abstrakt: | INTRODUCTION. High quality standards for sterilised water for injections arise from the need to guarantee the safety and effectiveness of injectable medicines, especially biologicals, since the presence of impurities in the solvent (mainly microbial contaminants, endotoxins, and heavy metals) can lead to serious adverse drug reactions. Therefore, it is important to determine the most promising approaches to assessing the quality of water for injections to develop the regulatory requirements for the Eurasian Economic Union (EAEU).AIM. This study aimed to analyse key trends in the quality assessment of water for injections used as a solvent for medicinal products.DISCUSSION. This study involved a retrospective comparison of the quality control requirements for water for injections established by the world’s major pharmacopoeias, including the State Pharmacopoeia of the Russian Federation, the United States Pharmacopeia, the Japanese Pharmacopoeia, the European Pharmacopoeia, the British Pharmacopoeia, the Pharmacopoeia, and the Pharmacopoeia of the People’s Republic of China. Additionally, the comparison included recommendations by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and the Pharmacopoeia Discussion Group. The past decade witnessed significant changes in the approach of international pharmacopoeias to the control of organic and inorganic impurities in water for injections, both in terms of analytical procedures and in terms of the number of tests required. According to the comparison, the most significant changes to the quality control requirements for sterilised water for injections in the finished dosage form were introduced by the European Pharmacopoeia in 2024. The authors considered the possibility to streamline the quality control procedure by reducing the number of tests and replacing the currently required ten qualitative tests for inorganic impurities with a single quantitative determination of electrical conductivity. This article ... |
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| DOI: | 10.30895/2221-996X-2025-25-1-97-110 |