Accelerating Impurity Identification and Characterization at Eli Lilly Scientists use analytical instrumentation, electronic laboratory notebooks, and specialized software for impurity identification and management. Case StudyIntroduction The identification and characterization of impurities in pharmaceutical drugs is critically important to ensure that their presence will not evoke any form of adverse response, either pharmacological or toxicological, in a patient taking the medication. Furthermore, attention must be made to the impact impurities can have on the production process and formulation. 1 Regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the International Congress on Harmonization (ICH) have established rigorous guidelines for the identificat

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