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comparison of impurities during site method transfer

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comparison of impurities during site method transfer

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srdales
What criteria are individuals using for a site transfer on an impurity method?

Differences of 30%, or 50% if you are comparing impurities less the 0.1%?

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JM
We use RSD of 15 % for impurities above 0.1 % and above LOQ. We do not consider impurities below 0.1 % during method transfer.

JM
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