drug api meaning
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Given their critical role, APIs must meet stringent quality standards to ensure patient safety and therapeutic efficacy. Regulatory agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) enforce guidelines that govern the development and manufacturing of APIs. This includes the necessity for rigorous testing to demonstrate purity, potency, and stability. Manufacturers must also provide comprehensive documentation, including master production and control records, to demonstrate compliance with regulatory standards.
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Structure and Properties
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Active Pharmaceutical Ingredients (APIs) are the essences of drugs, responsible for their therapeutic effects. However, the journey from concept to market-ready pharmaceuticals is complex and often relies heavily on intermediates—substances produced during the synthesis of an API. These API intermediates serve multiple purposes in drug development and manufacturing, offering a crucial bridge in the creation process.
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Understanding the Definition of Drug API
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While many people turn to supplements to fulfill their daily vitamin C requirements, it is always best to obtain nutrients from natural food sources. Some excellent sources of vitamin C include:
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