Other Considerations for QL.To account for instrument-to-instrument variation,

one may need to verify the QL in multiple runs using different instruments.

The desired QL should be less than the ICH reporting limit (e.g., 50% of ICH

reporting limit). QL should be appropriate; too high indicates that the method is

not sensitive enough to report results at the ICH reporting limit. Too low indicates

that insignificant degradation products, even though much lower than the ICH

reporting limit, may need to be reported.