Qualification is the process of establishing the biological safety of a product in the presence of a degradation compound or impurity above specified levels. A reasoned method must be used to establish acceptable criteria for impurities and must include the safety criteria considered. The interpretation of the regulation is very important todefine... Read More... "What is a qualification, why is it important?"
Label: compounds
Impurities and Degradation Compounds
What is a degradation compound in medicines and how does it affect us? Degradation compounds are substances produced by the breakdown of the active ingredient. Various impurities may result due to degradation of the active ingredient or some other interaction in storage, so stability studies need to be performed to ensure the safety of the product. Thepresence... Read More... "Impurities and Degradation Compounds".