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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...
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Once an API is identified, formulating it into a usable medication involves the incorporation of excipients. Excipients are inactive substances that serve as carriers for the API. They play several key roles in drug formulation, including improving the stability and bioavailability of the active ingredient, aiding in the manufacturing process, and ensuring the drug is easy and pleasant for patients to consume. Common excipients include fillers, binders, disintegrants, lubricants, and preservatives, which collectively support the API in achieving its therapeutic goal.
active pharmaceutical ingredient and excipient...