Pharmacopoeial Requirements - How to Change a Regulated Method

Over the last two centuries massive progress has been made around the globe to make drugs safe for consumers, both on a national as well as on an international level, thus assuring the potency of commercially available drug products. Depending where (in which country or region) a finalized drug product will be used it must meet the specified regulations and thus many pharmaceutical companies work from several pharmacopoeias. One of the more important improvements is the requirement for impurity profiling or in other words the analysis of related substances (RS) monographs. Assay and potency methods as well as identification of impurities are carried out with various analytical techniques. HPLC has especially been widely exploited for impurity profiling methods.