what are drug intermediates
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The quality, purity, and efficacy of an API are vital to ensuring the safety and effectiveness of the final pharmaceutical product. Regulatory bodies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), impose stringent guidelines and standards for the production and testing of APIs. Manufacturers must comply with Good Manufacturing Practices (GMP), which outline the necessary controls and documentation to guarantee that APIs are consistently produced to quality standards.
drug api definition...
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Ethylene glycol diacetate is a versatile intermediate used in the production of various pharmaceutical compounds. Its purity and consistency are vital for the synthesis of high-quality drugs. The presence of impurities in this intermediate can lead to contamination of the final product, posing serious health risks to patients. Therefore, manufacturers must implement stringent quality control measures to ensure the purity of ethylene glycol diacetate.
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