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High-quality pharmaceutical intermediates must comply with strict regulatory standards. These standards are set by organizations such as the FDA (Food and Drug Administration) and EMA (European Medicines Agency) to ensure the safety and efficacy of medications. The production process involves precise control of various parameters, including temperature, pH, and purity levels. For instance, ethylene glycol diacetate and sodium cumenesulfonate are common intermediates that must be produced under controlled conditions to maintain their quality and effectiveness.
Given the potential impact of APIs on public health, the manufacturing processes are subject to strict regulations. Regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), enforce Good Manufacturing Practices (GMP) to ensure the quality and safety of APIs. These regulations require rigorous quality control and assurance measures throughout the manufacturing process.
manufacturing of active pharmaceutical ingredients
