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- Posts: 520
- Joined: Fri Feb 10, 2012 7:39 pm
I've got a question about trace contribution of the product matrix: in this case a tiny peak that is not resolved from the peak of interest. The analyte of interest (the API) is significantly larger than any such response from a product placebo, typically more than 100 times larger or greater.
So the question is a general one: for selectivity, how small of contribution must the product matrix be and still be considered negligible for a cGMP test procedure and its validation? In the modern world of software and zooming, very little is "zero" these days. Thanks, and any official references or guidelines would be great.
Can we define a limit in our SOP, like any peak less than 0.5% of API peak area is insignificant? Thanks.