API (Active Pharmaceutical Ingredient)
An Active Pharmaceutical Ingredient is the substance in a medicine that produces its therapeutic effect. APIs are made by chemical synthesis, fermentation or extraction and must be manufactured under GMP to a defined specification, usually a pharmacopoeial monograph. A finished drug combines the API with excipients in a dosage form such as a tablet or injection.
Related terms
Drug Master File (DMF)
A Drug Master File is a confidential submission to a regulator, most often the US FDA, that describes how a s…
Excipient
Any component of a medicine other than the active ingredient. Excipients act as fillers, binders, disintegran…
GMP (Good Manufacturing Practice)
Good Manufacturing Practice is the set of quality rules that ensures medicines and their ingredients are cons…
Intermediate
A material produced during the steps of a synthesis that undergoes further chemical change before it becomes…
Read more about it
Have a list of compounds to price?
Paste up to 200 CAS numbers into Bulk CAS lookup, or send one enquiry for everything in your quote list. We reply with price, lead time and documents.