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Understanding the Role of APIs in Pharma Key Examples


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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Quality control is a critical part of the API production process. It ensures that the final product meets predetermined specifications for purity, potency, and contaminants. Various analytical techniques, such as high-performance liquid chromatography (HPLC) and mass spectrometry, are employed to monitor the quality of the API throughout the manufacturing process.


Coagulation works by altering the physical and chemical properties of suspended particles in water. When water contains various impurities such as silt, algae, and microorganisms, these particles often carry negative charges and repulse each other, preventing them from clumping together. Coagulants, which are typically positively charged, neutralize the negative charges of the impurities, allowing them to come together to form larger particles known as flocs.


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