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Stability

2021-01-06View Original

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In the production of active pharmaceutical ingredients, when changing the cleaning agents for equipment, is it necessary to conduct studies on the stability of the final product?
Reply #22021-01-06
In the production of pharmaceuticals, since most of the components in the final drug products are additives or dispersants, extremely high purity is required for the active pharmaceutical ingredients. When changing cleaning agents, it is necessary to determine whether the new agent is effective at removing impurities and to check whether any residues remain in the final product, as these residues could affect the stability of the product

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