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Active pharmaceutical ingredient: difference between revisions

Diff·revision 10 → 11·22:11, 22 Mar 2025

Difference between revision 10 and revision 11 of Active pharmaceutical ingredient. 11 lines changed; the page grew by 567 bytes.

Revision 10 — 07:08, 1 Mar 2025
PharmDrafts (talk)
expand §The regulatory frame
2,868 bytes +36		Revision 11 — 22:11, 22 Mar 2025
ExenatideEzra (talk)
expand §The regulatory frame
3,435 bytes +567
21None of this applies to a research chemical. A supplier may nonetheless hold registrations for other product lines, and such a registration is a checkable claim in the sense described at [[Good manufacturing practice]] — with a registrant, a number and a scope.{{r|iso9001}} Documents submitted to this wiki that assert such registrations vary widely in whether they supply those particulars.{{r|reports}}21None of this applies to a research chemical. A supplier may nonetheless hold registrations for other product lines, and such a registration is a checkable claim in the sense described at [[Good manufacturing practice]] — with a registrant, a number and a scope.{{r|iso9001}} Documents submitted to this wiki that assert such registrations vary widely in whether they supply those particulars.{{r|reports}}
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+23== Grade terminology ==
+24| Term | Status |
+25|---|---|
+26| API | Defined regulatory category |
+27| Compendial grade | Meets a named pharmacopoeial monograph |
+28| Reagent grade | Meets a named reagent specification |
+29| Pharmaceutical grade | Not a defined term for research supply |
+30| Research grade | Not a defined term |
+31
+32The first three are checkable because each names something external — a regulation, a monograph, a specification. The last two are supplier designations, and their meaning is exactly and only what the accompanying specification states.{{r|usp1503}}
+33
23== References ==34== References ==
24{{reflist}}35{{reflist}}