Impurity Specs for Drug Product

[jayroseville58]

Can Anyone teach me how to set known impurity specs as per ICH? I have three different tablet strengths. 5mg, 10mg and 15mg. Thanks.

[gtma]

Know impurity spec is generally set at the ICH qualification limit. Make sure you get tox opinion, for the limit may need to be set lower. Stats could also be used to set more meaningful spec...takes into consideration analytical and manuf variabilities. Don't forget to consider other approved specs e.g. line extensions