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Tag: API impurity profiling

Evaluating the Influence of Impurities on API Stability Profiles

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Evaluating the Influence of Impurities on API Stability Profiles Assessing the Impact of Impurities on the Stability of Active Pharmaceutical Ingredients Introduction The presence, formation, and behavior of impurities play a critical role in the stability of Active Pharmaceutical Ingredients (APIs). Impurities can originate from various sources—including synthesis by-products, degradation processes, residual solvents, or packaging…

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Impact of Impurities on API Stability Data, Stability Studies for APIs

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