enzima pqq
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The rigorous regulatory environment in which pharmaceutical companies operate has also influenced API manufacturing processes. Regulatory bodies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) enforce stringent guidelines to ensure the quality and safety of pharmaceuticals. Consequently, API manufacturers must invest heavily in quality control and compliance measures, making it imperative to adopt advanced technologies such as Process Analytical Technology (PAT). This enables real-time monitoring and control of production processes, ensuring that the end product consistently meets the required specifications.
api manufacture...
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In the case of finished pharmaceutical products, stability testing encompasses not just the API but also the entire formulation, including excipients, which are the inactive substances used to formulate the drug. The interactions between the API and excipients can affect the overall stability of the product. For example, moisture-sensitive APIs may require specific excipients that can provide a protective barrier against moisture uptake.
stability testing of active pharmaceutical ingredients and finished pharmaceutical products...