Impurity Profiling in Combination drugs!

Hi All,

Would like to have opinion of experts on " One combination drug is having three actives. Each active individually tested w.r.t. Impurity profiling. The question is specification for combination drug needs to be followed & method development of this drug w.r.t Impurity profiling required or Not".


Impurity profiling is most important.
-It needs levels of impurities
-Impurity type
-Solvent profile
-What is the total impurity in combination of product
-Is praticular impurity present in(Combination) one or more drugs and its final impurity quantity and its limits & effect.
-If you have qualified one vendor -take different lots/batchs and impurity variation chart.You need to make a trend analysis and also mark a regular limit of that.
-If you change a vendor–Reasons for change if its impurity and how much it was quantified?

Hi Mr. Durga,

Thanks for valuable sharing.

Infect opinions on finalizing the Specification for combination drug impurity profiling & their methodology also can be shared.