ABSTRACT
The assessment of degradation in pharmaceutical products involves two aspects of analytical measurement. First, a selective analytical method must be available for accurate assay of the parent drug compound, in order to correctly measure any loss. Second, methodology should be in place for quantification of the degradation products formed. Ideally, when degradation occurs, the measured amount of parent drug lost should correlate well with the measured increase in degradation products. This correlation is referred to as ‘‘mass balance’’(1). More recently, the International Conference on Harmonization (ICH) has provided a definition of ‘‘mass balance; material balance’’ as follows:
The process of adding together the assay value and levels of degradation products to see how closely these add up to 100% of the initial value, with due consideration of the margin of analytical precision. This concept is a useful scientific guide for evaluating data, but it is not achievable in all circumstances. The focus may instead be on assuring the specificity of the assay, the completeness
of the investigation of routes of degradation, and the use, if necessary, of identified degradants as indicators of the extent of degradation via particular mechanisms (2).
