Question { Jubilant Organosys, 50257 }

What is difference between Related Substance & Impurity
Profile?

Answer

related substances mean process related compounds and degradation compounds of drug substances or products.

Impurity profile is a description of the identified and unidentified impurities present in a typical batch of API or products.(Terms such as byproduct, transformation products, degradation products, interaction products, esidual solvents,related products and toxic impurities)