Q3A and Q3B guidelines for ICH?
Q3A impurities for new substance
Q3B impurities for new drug
In defined USP chapter 1086
Q3A and Q3B guidelines for ICH?
Q3A impurities for new substance
Q3B impurities for new drug
In defined USP chapter 1086
Organic impurities
Elemental impurities (inorganic)
Residual solvents