The active pharmaceutical ingredient (API) is also referred to as the drug substance. Both drug substance and API will be used interchangeably in this chapter.
API potency Drug API Potency. The effectiveness and therapeutic power of drugs depend on API (Active Pharmaceutical Ingredient) potency. An API s potency determines how well a drug can achieve its medicinal effect. A highly potent API will have a significant therapeutic effect at lower concentrations, making the drug more effective.
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Maintaining API potency is crucial for drug effectiveness. Medicine Formulation with API Potency Optimization. Medicine dosage concentration depends on API potency. High-potency APIs decrease dosage concentrations, making drugs more effective at lower doses. The drug s therapeutic effect and side effects are improved.
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A Drug is only active pharmaceutical ingredients (API). Medicine is the formulation of API with excipients or without excipients. Drug has no
Potency of drug means amount of drug needed to produce an effect of given intensity. It also indicate the maximum response which can be achieved with a drug. Potency Calculation of API for Batch Quantity. Quantity of API required (from single lot) = (Theoretical Quantity of API Working Assay of API) X 100 = X kg
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