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Abstract

REVIEW ARTICLE: IMPURITY PROFILING OF PHARMACEUTICAL DRUG SUBSTANCE AND DRUG PRODUCTS

Reddi Leelaprasanna*, P. Syamala, Y. Pooja and N. Ashritha

ABSTRACT

Impurity profiling is very important parameter of pharmaceutical industries. It is used to determine the quality of the pharmaceutical products. Impurities in pharmaceuticals are the surplus chemicals that stay behind with the active pharmaceutical ingredients (or) develop during formulation (or) upon aging of both active content and formulated active ingredients to medicines. The efficacy and safety of pharmaceutical product is affected by presence of unwanted traces of impurities. Impurity profiling plays an important role in the detection, identification, structural elucidation and quantitative determination of organic & inorganic impurities as well as residual solvents in bulk drug and pharmaceutical formulations. Various regulatory authorities like ICH, USFDA, Canadian drug & health agency are emphasizing the identification of impurities in active pharmaceutical ingredients. Identification of impurities is done by variety of chromatographic, spectroscopic and hyphenated techniques used either alone (or) in combination with other techniques.

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