3. ANALYTICAL PROCEDURES

The registration application should include documented evidence that the analytical procedures have been validated and are suitable for the detection and quantitation of degradation products ( see ICH Q2A and Q2B guidelines on analytica validation ) .As appropriate , this validation should include samples stored under relevant stress conditions : light , heat , humidity , acid/base hydrolysis , and oxidation .Differences between the analytical procedures used during development and those proposed for the commercial product should also be discussed .