APIs play a pivotal role in the formulation of medications. Without APIs, there would be no therapeutic benefits from pharmaceuticals; the drugs would merely be inert substances. Consequently, the quality, efficacy, and safety of an API directly influence the drug’s overall performance. Regulatory agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) mandate rigorous testing and quality control measures during the production of APIs to ensure that they meet specific safety and efficacy standards.
For APIs, stability testing serves to assess how the chemical, physical, and biological characteristics of the ingredient change over time. Various factors can influence API stability, including temperature, moisture, light exposure, and the presence of catalytic substances. Testing is generally conducted according to guidelines established by regulatory bodies such as the International Council for Harmonisation (ICH).
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Moreover, both PQQ and CoQ10 have shown promise in supporting brain health. PQQ’s neuroprotective effects, when combined with CoQ10’s ability to improve mitochondrial efficiency in brain cells, could potentially offer a powerful strategy for maintaining cognitive health as we age.