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Frequently Asked Questions
Enzalutamide impurities can be detected and quantified using various analytical techniques, high-performance liquid chromatography (HPLC), and mass spectrometry.
Enzalutamide impurities are monitored regularly during drug development, manufacturing, and post-marketing surveillance to ensure the quality and safety of the drug.
Enzalutamide impurities affect patient safety due to toxicity, reduced efficacy, and increased risk of side effects.
Purification techniques, such as recrystallization and chromatography, help reduce the level of impurities in Enzalutamide.
N-desmethyl Enzalutamide, a known metabolite of the drug, is an impurity of concern. It has been found to have anti-androgenic activity and could potentially reduce the efficacy of Enzalutamide.
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