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1 result for “Genotoxic Impurities”

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Review ArticleOpen accessPhrase in the titleSelected Genotoxic Impurities Profiling During WFI Qualification to Control Carcinogenesis in Large Volume ParenteralsMohabbat UllahWater For Injections (WFI) which is the main vehicle of Large Volume Parenterals (LVPs) should be free from trace amount of genotoxic impurities. This review gives emphasis on quantification of genotoxic trace metals during qualification of WFI in LVPs manufacturing unit. According to ICH guidelines, impurities related to drug substances are classified into three main categories: Organic impurities, inorganic (elemental) … …American Journal of Pharmacology and Toxicology, Vol. 10, Issue 1 · 27 May 2015 · 7,708 accessesView PDFCite