forced degradation questions

[olivia]

my API does not dissolve in water but it is soluble in ethanol.

For forced degradation study would I dissolve in ethanol and then stress three separate solutions with acid, base and peroxide.

For the heat and light stress would I stress the API without putting in to solution.


Hope someone can help

Liv.

[krickos]

Hi Olivia

First:
Actually ICH Q1A allows you to use a suspension of the API if you can not get it dissolved in water.

Of course you are more likely to get better information if you expose the API in dissolved form for various pH. You can always try to prepare a number of bufferts with low amounts of salts with known pH, dissolve the API in ethanol and then add buffert.

Also some APIs may not dissolve in water but dissolves in low pH.

As I said a suspension will do if nothing else works.