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Insoluble impurities in parenteral drugs
Just joined the group and am looking forward to some hopefully valuable interactions with reg affairs colleagues. Thanks in advance for any input. My question is: Is anyone aware of any guidances or have had FDA interactions regarding quantitation and allowable levels of submicron size insoluble impurities in parenteral products? -------------------------------------------- David Korman dkorman@elancorp.com Elan Pharmaceutical Technologies -------------------------------------------- |
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