HPLC assay was performed in triplicate, two of results were within specification, but one of the result showed out of specification (OOS). What are the rationals behind it?
One result is out of specification????What does its means? Can you clarify ???
Yes please clarify....question is not clear...what I understand is you analyse either three samples ,batches of some compound using a single assay and 2 results passed as per your company spec but one failed.
if this is the case then:
1. sample degrades (check validation report for stability)
2. system is showing error. (use bracketing std after every 5 samples and check it pass or not)
3. analyst is making some error. (Change the analyst)
Hope this will help
Clarififaction: HPLC assay was performed for a same batch of API in triplicate, two of results were within specification (Assay 99-101%), but one of the result showed out of specification (OOS). What are the rationals behind it?
the possible failures from the instrument are Injector and the other one may be the sample preparation.
if the analyst is enough experienced to prepare the matrix we always can not take the preparation would be a mistake
some times calibration of injector fails it may take 12ul instead of 10ul and many analysts would calibrate it under pass criterion, so my guess would be the injector is culprit
check the vials, that giving OOS the impact of the syringe was it correct.
check the preparations
check the suitability system
reinject
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