Active pharmaceutical ingredient (revision 1)
Old revision·09:00, 25 Nov 2024·SyringeSybille
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| Active pharmaceutical ingredient | |
|---|---|
| Abbreviation | API |
| Definition source | ICH Q7 |
| Distinct from | Excipient; finished product |
| Registered in | A drug master file in many jurisdictions |
| Topic infobox · conventions | |
An active pharmaceutical ingredient (API) is a substance intended to be used in the manufacture of a medicinal product and to furnish pharmacological activity in it. The term is a regulatory category rather than a chemical one: the same molecule is an API when destined for a medicine and is not when destined for laboratory research.[1]
That distinction determines which requirements apply. API manufacture is subject to GMP and to registration in many jurisdictions; the same chemistry performed for research supply is not.[1]
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