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WebFeb 1, 2024 · An unknown impurity was detected at RT 5.8 min, eluting between methyl paraben and T3 (Fig. 2) and the content of this impurity was found to be about 0.5% (with respect to T4) in this unexpired sample of OS product. Download : Download high-res image (69KB) Download : Download full-size image; Fig. 2. WebSep 27, 2010 · Since 2007, guidelines from the European Medicines Agency and a draft version from the U.S. Food & Drug Administration have called on the drug industry to reduce DNA-reactive genotoxic impurities (GTIs) in pharmaceuticals. The EMA guidelines suggest only that GTIs should be detected and quantified by “state-of-the-art analytical techniques.” WebImpurities can be classified into the following categories: • Organic impurities (process- and drug-related) • Inorganic impurities • Residual solvents Organic impurities can arise during the manufacturing process and/or storage of the new drug substance. They can be identified or unidentified, volatile or non-volatile, and include: driver genius 12 professional download