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KMID : 0385520220350030093
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Analytical Science & Technology
2022 Volume.35 No. 3 p.93 ~ p.115
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Analytical methods to manage potential impurities in drug substances
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Park Kyung-Min
Kim Won-Mi
Ahn Su-Hyun
Lee Ha-Lim
Hwang Su-Hyeon
Lee Won-Woong
Hong Jong-Ki
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Abstract
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Potential impurities in pharmaceuticals could be produced during manufacture, distribution, and storage and affect quality and safety of pharmaceuticals. In particular, highly reactive impurities could result in carcinogenic (mutagenic) effects on human body. International Conference on Harmonisation (ICH) has provided M7(R1) guideline for "Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk" and recommended an adoption of this guideline to the authorities. ICH M7(R1) guideline provides classification, accepted intakes, and controls of potential impurities in pharmaceuticals. However, since appropriate and unified analytical methods for impurities in pharmaceuticals have not been provided in this guideline, most potential impurities in pharmaceuticals are still difficult to manage and supervise by pharmaceutical companies and regulatory authorities, respectively. In this review, we briefly described definition of unintended mutagenic impurities, basic information in ICH M7(R1) guideline, and analytical methods to determine potential impurities. This review would be helpful to manage and supervise potential impurities in pharmaceuticals by pharmaceutical companies and regulatory authorities.
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KEYWORD
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potential impurity, mutagenic (carcinogenic) impurity, active pharmaceutical ingredient, drug substance, ICH M7(R1), analytical method
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