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The pharmaceutical intermediate market is subject to stringent regulatory oversight. Regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), impose strict guidelines to ensure the safety and efficacy of pharmaceutical products. Manufacturers must adhere to Good Manufacturing Practices (GMP) and other regulations to ensure that intermediates meet quality standards.
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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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Avoid using Vitamin C products in conjunction with products containing alpha hydroxy acids (AHAs) or beta hydroxy acids (BHAs) to prevent potential irritation.
