pharmaceutical intermediate definition

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The half-life of a substance is the time it takes for half of the compound to be eliminated from the body, and it can significantly affect how often one should take it to maintain effective levels. For PQQ, studies indicate that its half-life is relatively short, ranging from a few hours to approximately 20 hours, depending on various factors such as individual metabolism, dosage, and the method of administration.


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API manufacturing can be broadly categorized into two methods chemical synthesis and biotechnological processes. Chemical synthesis involves the creation of APIs through chemical reactions, often requiring multiple steps to achieve the final product. This approach is well-established and can be scaled effectively, making it suitable for small-molecule drugs.


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Quality control (QC) and quality assurance (QA) are fundamental components of the API manufacturing process. All steps of manufacturing must meet stringent regulatory requirements set by authorities such as the FDA or EMA. QC involves rigorous testing of raw materials and the intermediate and final products to ensure they meet predefined standards. These tests often include chemical analysis, microbiological testing, and stability studies. QA, on the other hand, encompasses the overall system of procedures and protocols that ensure consistent production quality, including documentation practices, employee training, and validation of equipment.


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