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Inverted condition stability for lyohilised products (injections) with liquid as diluent

Contribution from shekhar dabholkar written on 7/11/2008 at 08:58

In EU , is it necessay to perform upright condition stability analaysis for drug products packed in vials / rubber closures if stability at inverted condition ( considered as worst case ) is performed at all stability stations.
In case stability fails at a particular station in inverted position can we initiate analysis of upright samples ?

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