Dear Rejaneesh,
I find ICH Q3B says:
"In summary, the new drug product specification
should include, where applicable, the following
list of degradation products:
· Each specified identified degradation product
· Each specified unidentified degradation product
· Any unspecified degradation product with
an acceptance criterion of not more than (£) the
identification threshold
· Total degradation products."
I think the specification of your PD should be
established according to related guides firstly.
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