REGULATORY ASPECTS FOR IMPURITY PROFILING OF PHARMACEUTICAL PRODUCTS: AN OVERVIEW
AbstractPharmaceutical impurities are the organic and inorganic unwanted chemicals which are found in active pharmaceutical ingredient after synthesis or develop during formulation development. These impurities severely affect the safety and efficacy of developed pharmaceutical product. Impurity profiling detects and quantifies the levels of organic and inorganic impurities and thereby helps in better monitoring of quality, stability and safety of pharmaceutical products. Regulatory bodies worldwide are serious towards presence of impurities and impurity profiling has thus become an important step in filling drug dossiers. The ICH guidelines on impurity have clearly defined the levels of toxic impurities and have become benchmark in establishing impurities in pharmaceutical drug products. The present article summarizes the concept of impurity profiling and also presents a case study on impurity profiling of methamphetamine hydrochloride to illustrate its significance. Further a case study is presented on quantification of active pharmaceutical ingredient and impurities in sildenafil citrate purchased via internet and its relative outcomes.
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