ABSTRACT

Active Pharmaceutical Ingredient (API) (or Drug Substance)—Any substance or mixture of substances intended to be used in manufacture of a drug (medicinal) product and that, when used in production of drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body. API Starting Material-A raw material, intermediate, or an API that is used in the production of an API and that is incorporated as a significant structural fragment into the structure of the API. API Starting Materials are normally of defined chemical properties and structure. In the case of continuous production, a batch may correspond to defined fraction of production. Calibration-The demonstration that a particular instrument or device produces results within specified limits by comparison with those produced by a reference or traceable standard over an appropriate range of measurements.