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Antibiotic impurity guideline

http://www.chromforum.org/viewtopic.php?t=20293

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Antibiotic impurity guideline

Posted: Mon Jul 16, 2012 6:53 am
by prepcolumn
Hi

EMA has launched the final guidance for antibiotics. I really wonder you guys find these limits realistic when evaluating the delta 2 or 3 isomers, e-isomers, open rings etc?

http://www.ema.europa.eu/docs/en_GB/doc ... 129997.pdf
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