Spike-and-recover accuracy for a peptide assay

Noted, and thank you for writing it out rather than summarising it.

I read post #24 twice before replying, because I had assumed the opposite.

Where a pharmacopoeial monograph exists, a method that follows it inherits a great deal of assurance. Almost nothing discussed here has one.

The right answer here may simply be that it has not been measured.

Worth separating spike-and-recover accuracy as a question about the compound from spike-and-recover accuracy as a question about the documentation. They get answered by different people and only one of them is answerable here.

The limit of quantitation determines what the impurity table can honestly contain. Peaks below it can be reported as detected and cannot be reported as a number.

The limit of quantitation determines what the impurity table can honestly contain. Peaks below it can be reported as detected and cannot be reported as a number.

I would call that likely rather than established.

Thank you for taking the time. That was more work than a reply usually is.

The most useful single question about a method: what would it fail to detect? Every method has an answer and few documents state it.

Take the reasoning and check the arithmetic; I do not always get it right.

On post #110 — agreed on the reasoning, with one qualification.

The most useful single question about a method: what would it fail to detect? Every method has an answer and few documents state it.

Where a pharmacopoeial monograph exists, a method that follows it inherits a great deal of assurance. Almost nothing discussed here has one.

If that is already documented somewhere, ignore me and link it.