Guidelines and strategy of the International Conference of Harmonization (ICH) and its member states to overcome existing impurity control problems for antibiotics in China

Yu, Jiang; Xia, Jun-Ping; Yang, Jianhong; Zhang, Zhefeng; Hu, Chang‐Qin; Zhang, Zhirong

doi:10.1016/s1875-5364(15)30044-3

Cited by 2 publications

(2 citation statements)

References 26 publications

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“…и ОФС «Фармацевтические субстанции» 8 . В 2012 г. Европейским агентством по лекарственным средствам (European Medicines Agency, ЕМА) было утверждено руководство 9 по составлению спецификаций для родственных примесей в антибиотиках [1]. Поскольку это руководство действует практически 10 лет и нормативная база ЕАЭС создается на основе документов Европейского союза, оценка применения принципов этого руководства в частных фармакопейных статьях ведущих зарубежных фармакопей и Государственной фармакопеи Российской Федерации (ГФ РФ) для контроля примесей в антибиотиках имеет научно-практическое значение.…”

Section: Introductionunclassified

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Control of Organic Impurities in Semisynthetic Antibiotics

Ковалева¹,

Arhipova²,

Bulova³

et al. 2022

Vedomosti Nauchnogo tsentra ekspertizy sredstv meditsinskogo pr

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In 2012, the European Medicines Agency (EMA) adopted a guideline, which divided all antibiotics into groups according to the manufacturing process and established acceptance criteria for organic impurities for each of the groups.The aim of the study was to justify the requirements and methodological approaches to setting the limits for organic impurities in semisynthetic antibiotics.Materials and methods: the authors analysed the requirements established by the leading world pharmacopoeias and the State Pharmacopoeia of the Russian Federation regarding the control of organic impurities in semisynthetic antibiotics, using the example of four semisynthetic antibiotics: doxycyline hyclate, clarithromycin, meropenem, and ceftriaxone. The study used the methods of comparative analysis and content analysis. Results: the study demonstrated that the organic impurity profiles of the analysed active substances and the corresponding finished medicinal products often differ significantly across the leading pharmacopoeias, either qualitatively or quantitatively. The Russian, European, and United States pharmacopoeias provide for the use of impurity reference standards in the test procedures for the determination of impurities in active substances of the semisynthetic antibiotics in question, whereas the Japanese Pharmacopoeia allows the use of non-compendial reference substances in the assessment of the chromatographic system separation power.Conclusions: the ability of a pharmacopoeial text to cover a variety of medicinal products coming to the Russian market from different countries has become a vital issue. This includes covering the impurity determination procedures, reference standards, and limits used, because general-purpose methods and limits do not always allow for correct assessment of impurity profiles in substances produced by different manufacturing processes. The current USP practice is to include various impurity control procedures in monographs on medicinal products, and the limits may also vary. This approach may be applied in the State Pharmacopoeia of the Russian Federation as well.

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Section: Introductionunclassified

“…1 Контроль органических примесей в полусинтетических антибиотиках Ковалева Е.Л., Архипова К.С., Булова Е.А., Стралковская А.А., Терентьева О.О.…”

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Control of Organic Impurities in Semisynthetic Antibiotics

Ковалева¹,

Arhipova²,

Bulova³

et al. 2022

Vedomosti Nauchnogo tsentra ekspertizy sredstv meditsinskogo pr

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Control of organic impurities in antibiotics

Kovaleva,

Arkhipova,

Terentieva

2024

Farmaciya

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Introduction: the international, as well as Russian Pharmacopoeia criteria for organic impurity assessment are not applicable to medicinal products obtained by fermentation, therefore the setting of limits for product-related impurities in antibiotics is not regulated by any commonly shared rules. The aim of the study was to analyse and summariese pharmacopoeial requirements for and methodological approaches to organic impurities control in active substances and finished products of semisynthetic antibiotics, peptide antibiotics, and antibiotics obtained by fermentation. Material and methods: the authors analysed the requirements for organic impurities control, as established by the leading world pharmacopoeias and the State Pharmacopoeia of the Russian Federation, using the example of three different groups of antibiotics (semisynthetic antibiotics, antibiotics obtained by fermentation, and peptide antibiotics). The study used comparative analysis and content analysis methods. Results: the study demonstrated that the product-related impurity profiles of the analysed active substances and corresponding finished products often differ significantly across the leading pharmacopoeias, either qualitatively or quantitatively, and do not necessarily comply with the EMA Guideline on setting specifications for related impurities in antibiotics. The methodological approaches to product-related impurity control also differ a lot in terms of pharmacopoeial reference standards used, accelerated stability studies, etc. Conclusion: the complex composition of product-related compounds does not always allow for their unambiguous classification as either impurities or active moieties (e.g. in the case of bleomycin). Most Russian Pharmacopoeia antibiotic monographs are harmonised with the European Pharmacopoeia (Ph. Eur.), which is fraught with problems regarding reference standards (RSs) use, since the composition of Ph. Eur. RSs includes both the active substance and several (sometimes up to 8) impurities. The Russian Pharmacopoeia monographs on antibiotics obtained by a process involving the fermentation stage, include the abnormal toxicity test, which seems redundant in comprehensive impurity control, at least for semisynthetic antibiotics.

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Guidelines and strategy of the International Conference of Harmonization (ICH) and its member states to overcome existing impurity control problems for antibiotics in China

Cited by 2 publications

References 26 publications

Control of Organic Impurities in Semisynthetic Antibiotics

Control of Organic Impurities in Semisynthetic Antibiotics

Control of organic impurities in antibiotics

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