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Related Substances HPLC Method Validation

http://www.chromforum.org/viewtopic.php?t=115534

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Related Substances HPLC Method Validation

Posted: Wed Feb 02, 2022 11:46 am
by Mouleyre
From a Compliance perspective, must the batch being used for a Related Substances method validation be within the proposed spec for all the impurities? Is it ok to go ahead with validation if one of the unknown impurities is OOS?
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