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API Quality Control

Meaning

API Quality Control refers to the rigorous, systematic set of testing procedures and checks implemented throughout the manufacturing process of an Active Pharmaceutical Ingredient to ensure it meets predetermined standards of identity, strength, purity, and quality. This critical pharmaceutical practice is the cornerstone of patient safety and therapeutic efficacy, guaranteeing that the core substance responsible for the drug’s effect is consistent and free from unacceptable levels of contaminants or degradation products. In the context of hormonal therapies, this control is paramount to ensure precise dosing and predictable endocrine responses.