Light stability of norethindrone and ethinyl estradiol formulation with FD&C colorants

In general, light-sensitive tablets exhibit discoloration in the surface layer(s) only. A case is discussed where a quantitative interaction between a drug, ethinyl estradiol (in a combination tablet containing norethindrone and ethinyl estradiol), and a dye (FD&C Red No. 3) occurs, and discoloration exists throughout the tablet. The data suggest that accelerated light studies should be carried further than those dictated by predictive periods so that equilibrium levels can be deduced.