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The impurities do not necessarily imply harm, but their levels and nature need careful regulation. Health authorities set specific limits for impurity levels based on safety and efficacy considerations.
Impurities in Nintedanib can affect its effectiveness by altering the drug's pharmacokinetics, pharmacodynamics, or stability. Controlling them ensures the drug maintains its therapeutic potency and delivers the desired outcome.
Analytical techniques such as High-Performance Liquid Chromatography (HPLC), Mass Spectrometry (MS) help detect and quantify Nintedanib impurities. These methods enable accurate identification and measurement of impurity levels.
Nintedanib impurities should be stored at a controlled room temperature between 2-8°C or as indicated on the Certificate of Analysis (CoA).
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