Description

Active Pharmaceutical Ingredient: Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product. Pharmaceutical Ingredient refers to a substance or substance combination used in manufacturing a drug product

pharmaceutical ingredients (APIs) and pharmaceutical drug products, both chemical drugs and biologics, are essential for product quality and patient protection. The goals of specification setting are (1) to determine appropriate and safe limits or quantitative ranges during clinical development and (2) to justify specifications for the product to enter the market.