Hello, i got some questions about the stress studies. I need to stress one drug product for specificity validation.

Question 1: The two active ingrediants
in the drug are not dissolved in water. How can i stress the product or the two active ingredients under 0.1 N HCl and 0.1 N NaOH conditions?

Question 2: how i can differenciate between stressing the product and stressing the drug substances? When am i supposed to stress the product itself?
i am confused about the above issues. your suggestions are greatly appreciated.

Thanks in advance.

Solubilise the drug in say 5mL of Methanol or Acetonitrile and then treat the drug with acid or alkali or peroxide.

hello

i think u need only stress the drug substance,if it shows any impurity which are not seen during stressing the drug product analysis,it shows the drug product to be stable.

for drug product u have to see the placebo interference,and not to worry about impurities seen in drug substance.

s vishnani