4. ANALYTICAL PROCEDURES

The registration application should include documented evidence that the analytical procedures are validated and s suitable for the detection and quantification of impurities ( see ICH Q2A and Q2B Guidelines for Analytical Validation ) .Thus , the use of lower precision techniques ( e . g . , thin-layer chromatography ) can be acceptable where justified and appropriately validated .Differences in the analytical procedures used during development and those proposed for the commercial product should be discussed in the registration application .