Dear Forum',
If an API impurity has a structure alert motif (e.g. styrene).
In such cases, considering the presumption, the gennotoxic potential of API impurity is because of Structure alert motif, the limit for API impurity based on structure alert (e.g.styrene) reference dose (RfD) could be fixed in API release specs???
Kindly advice. It would be a great help.
Many-many thanks in advance
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Sushil Sharma
Visakhapatnam
India
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