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Moreover, real-time stability studies are conducted under recommended storage conditions. These long-term studies are essential as they help to validate the findings from accelerated studies, providing a comprehensive understanding of how the API will function during its intended shelf life. The data obtained from these stability tests inform pharmaceutical manufacturers about necessary measures for handling, packaging, and labeling, ensuring that the needs of regulatory agencies, such as the FDA or EMA, are met.


 

After synthesis, the crude API needs to be purified to eliminate impurities and obtain the desired purity level, often 98% or higher. Common purification techniques include recrystallization, distillation, chromatography, and membrane filtration. Each technique has its advantages and is selected based on the specific characteristics of the API. The purification process is critical as impurities can significantly impact the safety and efficacy of the final pharmaceutical product.


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