Active pharmaceutical ingredient: difference between revisions
Diff·revision 17 → 18·15:56, 28 Jul 2025
Difference between revision 17 and revision 18 of Active pharmaceutical ingredient. 5 lines changed; the page grew by 576 bytes.
| Revision 17 — 13:54, 8 Jul 2025 FiveOhThreeB (talk) correct the agency abbreviation at first use 3,779 bytes +24 | Revision 18 — 15:56, 28 Jul 2025 FiveOhThreeA (talk) rm a duplicated category 4,355 bytes +576 | ||
|---|---|---|---|
| 34 | This is not a criticism of suppliers using the terms. It is an observation that a grade name is not a specification, and that the question worth asking of any grade claim is which document defines it. | 34 | This is not a criticism of suppliers using the terms. It is an observation that a grade name is not a specification, and that the question worth asking of any grade claim is which document defines it. |
| 35 | 35 | ||
| + | 36 | == Why the distinction is often blurred == | |
| + | 37 | The same molecule, made by the same chemistry, in the same facility, may be an API for one customer and a research chemical for another. The difference lies in the quality system applied and the documentation generated, not in the atoms.{{r|ich_q7}} | |
| + | 38 | ||
| + | 39 | This is why claims of the form "made on the same line as pharmaceutical material" are hard to evaluate. They may be true and yet say nothing about whether the batch in question was made under the same controls, since GMP applies to a process and its records rather than to a room. | |
| + | 40 | ||
| 36 | == References == | 41 | == References == |
| 37 | {{reflist}} | 42 | {{reflist}} |