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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.
api in pharmaceutical manufacturing

Once an API is developed, it undergoes rigorous testing to ensure its safety and efficacy. This includes preclinical studies, often conducted in vitro (in test tubes) and in vivo (in live organisms), followed by multiple phases of clinical trials with human subjects. Each phase aims to assess different aspects, such as dosage safety, effectiveness, and adverse effects. This stringency is crucial, as even small changes in the API's chemistry can significantly affect the drug's performance and safety profile.
example of active pharmaceutical ingredient
