Determination of Organic Impurities in Combination Drugs

Resumo

Methodological approaches to the control of organic impurities in drugs containing two and more active pharmaceutical ingredients are reviewed. Approaches of leading foreign pharmacopoeias (British, USA, Japanese) to assessing impurity profiles in combination drugs are analyzed. The methods for assessing impurities that carry the largest safety risks for combination drugs are determined. It is demonstrated that a unified approach to the control of organic impurities in combination drugs is needed.