Manufacture of sterile active pharmaceutical ingredients

Active Pharmaceutical Ingredient (API)

Any substance or mixture of substances intended to be used in the manufacture of a drug
(medicinal) 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 effect the structure and function of the body
Note: Active pharmaceutical ingredients are usually first obtained in the crude state.
Subsequent production operations convert the crude material to the final API that meets the
pharmacopoeial and/or similar requirements.
A sterile API is an API that has been subjected to additional processing steps to remove microorganisms,
particles and/or endotoxins.