Discussion
A system suitability test gives the following.
| Parameter | Result | Limit |
|---|---|---|
| Plate number | 4200 | Not less than 5000 |
| Tailing factor | 1.3 | Not more than 2.0 |
| Repeatability | 0.6 per cent | Not more than 1.0 per cent |
What should be done?
Answer: C
The plate number has fallen below its limit, which points at a degraded or partly blocked column, and the batch must not proceed until it is resolved. Passing two criteria out of three is not passing, wavelength does not affect efficiency, and a larger injection would reduce the plate count further. A suitability test that is overridden when it fails serves no purpose at all, which is the point of setting the limits in advance. Checking the units of each quantity catches a wrong formula before the arithmetic begins.
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