Active pharmaceutical ingredient (revision 2)
Old revision·02:17, 29 Nov 2024·LabelLibby
| 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]
The regulatory frame
[edit]Guidance for APIs covers the same ground as finished-product GMP, adapted to bulk substance: materials, process controls, validation, records, and the point in a process at which GMP begins to apply — which for a synthetic API is generally the introduction of the starting material into the process.[1]
Registration mechanisms vary. A drug master file allows a manufacturer to submit confidential process detail to a regulator and to authorise a customer to reference it; other jurisdictions use certificates of suitability or direct registration.