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The production of APIs involves several stages, including discovery, synthesis, purification, and characterization. Interestingly, API development is one of the most complex aspects of drug development due to the need for high levels of precision and adherence to regulatory standards. The synthesis of APIs often requires advanced knowledge of organic chemistry, as well as access to sophisticated laboratories and equipment.
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3. Characterization After purification, extensive characterization is conducted to assess the quality and potency of the APIs. This includes various analytical techniques such as High-Performance Liquid Chromatography (HPLC), mass spectrometry, and nuclear magnetic resonance spectroscopy, ensuring that every batch meets stringent specifications.
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