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Stability studies typically involve long-term, accelerated, and intermediate testing. Long-term studies provide information about the API’s stability under normal storage conditions, often conducted over a period of 12 months or more. Accelerated testing involves higher temperatures and humidity levels to expedite decomposition, allowing manufacturers to predict long-term stability in a shorter time frame. Intermediate testing often serves as a bridge, assessing stability under conditions that fall between long-term and accelerated studies.


Moreover, the rise of biopharmaceuticals has led to a growing interest in biotechnological methods of API production. Using living organisms or cells to produce complex molecules, these methods often yield APIs that are difficult to synthesize chemically, opening new avenues for drug discovery.


What is PQQ?


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