Drug-Product-Impurity-Thresholds As per ICH Q3
Reporting/Identification/Qualification of Impurities.
Drug-Substance-Impurity-Thresholds As per ICH Q3
Types of Impurities- Organic Impurity (Degradation), In-organic impurity, Residual solvents (Class-I,II,III), elemental impurities, byproduct, heavy metals, reagents,ligands, salt, catalyst, toxic, process, leaching, Hydrolysis, Oxidation, reduction, stability, heat, light, contamination.
Elemental Impurities- Lead, Mercury,cadmium, Nickel,cobalt, arsenic. (USP-232,233)
