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The regulatory bodies, such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA), play a crucial role in this process. They evaluate the data submitted by pharmaceutical companies, including the formulation, manufacturing process, and clinical trial outcomes. This thorough review ensures that only safe and effective medications reach the market.
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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.
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2. Secondary Anti-Static Additives These additives work differently; rather than providing immediate anti-static properties, they modify the material's properties over time. Secondary additives often include carbon black, metal powders, or other conductive fillers that create a conductive network within the plastic matrix. This allows static electricity to dissipate more effectively over the lifespan of the product.
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