The American Chemistry Council
Any substance or mixture of substances, intended to be used in the manufacture of a drug product and that, when used in the production of a 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 or any function of the body of humans or animals. [1] [8] [13] [15] [16] [19]
A substance added to the excipient to improve or maintain a characteristic such as a preservative, flow agent, antimicrobial, etc.
Acceptable Daily Intake
Absorption, distribution, metabolism and excretion
Authorised Economic Operator
Aflatoxins are a group of structurally related toxic compounds produced by certain strains of the fungi Aspergillus flavus and A. parasiticus. Under favorable conditions of temperature and humidity, these fungi grow on certain foods and feeds, resulting in the production of aflatoxins. The most pronounced contamination has been encountered in tree nuts, peanuts, and other oilseeds, including corn and cottonseed. [24]
The American Institute of Baking
Agenzia italiana del Farmaco (Italy)
A substance that causes an abnormal response by the immune system (e.g. gastrointestinal disturbances and skin irritations, to anaphylaxis, anaphylactic shock and death) to certain proteins found in the substance. [25]
Contains and/or manufactured with starting materials of animal origin. [26]
American National Standards Institute
National Agency for Medicines and Health Products Safety (France)
Agência Nacional de Vigilância Sanitária (Brazil)
Active Pharmaceutical Ingredient
Excipient, food additive or personal care ingredient that is being used as an “active ingredient” in a formulation.