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On the other hand, excipients are the non-active components of a drug formulation that serve as vehicles for the API. They may enhance the stability of the medication, aid in the manufacturing process, improve taste, or assist in the drug's absorption in the body. Common excipients include fillers, binders, preservatives, and flavoring agents. For instance, lactose is often used as a filler in tablets, while magnesium stearate serves as a lubricant during production. Although they do not provide therapeutic effects, excipients can influence the bioavailability and efficacy of the active ingredients, making their selection critical in drug formulation.


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Failure to comply with these regulations can result in severe repercussions, including product recalls, fines, and legal liabilities. As such, the integration of regulatory considerations into the API manufacturing process is paramount for ensuring the consistent quality and safety of pharmaceutical products.


Before water undergoes reverse osmosis, it often passes through pre-treatment processes such as filtration. Flocculants and coagulants are chemicals used in these stages to promote the aggregation of suspended solids, making it easier to remove them from the water. By improving the quality of the feed water before it enters the RO unit, these chemicals help reduce the load on the membranes, thus improving their efficiency and lifespan.


3. Quality Assurance and Regulatory Considerations

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