Hi, Nitrosamine impurity formation, required conditions DMF, amines , nitrous acid, sodium nitrate .
In our process we are using DMF solvent only , Its intermediate products,
It’s required to perform NDMA, NDEA test.
Thank you,
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Regarding recent nitrosamines statement issued by FDA last year to assess infusion bag packaging - is it expected to assess the tertiary packaging , ie the shipper? As assume it is ultra low risk a nitrosamine from the shipper ends up going through the secondary overwrap and primary bag into the drug product