State robustness and intermediate precision

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1) What is the difference between an instrument detection limit and a method detection limit? (Select all that apply.)

The instrument detection limit is obtained by preparing and analyzing many independent samples.

The method detection limit is obtained by replicate measurements of aliquots from one sample.

There is more variability in the instrument detection limit, so it should be higher than the method detection limit.

The method detection limit is obtained by preparing and analyzing many independent samples.

The instrument detection limit is obtained by replicate measurements of aliquots from one sample.

There is more variability in the method detection limit, so it should be higher than the instrument detection limit.

2) What is the difference between robustness and intermediate precision?

Intermediate precision is the ability of an analytical method to be unaffected by small deliberate changes in operating parameters.

Robustness is the ability of an analytical method to be unaffected by small deliberate changes in operating parameters.

When demonstrating intermediate precision, the experimental conditions are intended to be the same in each analysis.

Robustness is a measure of precision. It is the variation observed when an assay is performed by different people on different instruments on different days in

the same lab. Each analysis might incorporate independently prepared reagents and different lots of the same chromatography column from one manufacturer.

When measuring intermediate precision, conditions are intentionally varied by small amounts.

When measuring robustness, conditions are intentionally varied by small amounts.

When demonstrating robustness, the experimental conditions are intended to be the same in each analysis.

Intermediate precision is the variation observed when an assay is performed by different people on different instruments on different days in the same lab. Each

analysis might incorporate independently prepared reagents and different lots of the same chromatography column from one manufacturer.

Reference no: EM13179032

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