Abstract

RECENT APPROACHES TO DECREASE NITROSO IMPURITIES FROM PHARMACEUTICAL AND CARCINOGENIC DRUGS

Vaishali Anil Bhutambare*

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Abstract

The control of Nitrosamine impurities which are potentially mutagenic and carcinogenic found in Pharmaceutical products play important role in evaluating carcinogenic risk to humans. The recent discovery of nitrosamine impurities in some marketed pharmaceutical drugs has increased mutagenic and carcinogenic potential. As per International Agency for Research on Cancer (IARC), nitrosamine is the chemically classified as a probable human carcinogen.[1] The various regulatory authorities have published the press release or notice regarding the control of nitrosamine impurities with the interim limit. Validated analytical methods are used to identify and quantify the nitrosamine impurities to the trace level at a given interim limit.[2,20] Medicine regulatory authorities like FDA, EMA, TGA and Health Canada have published several public notices to guide the manufacturer to control and limit these impurities to acceptable intake level.[22,24]

Keywords: Nitrosamine, Carcinogenic Drugs, Impurities, Analytical Methods and Guidelines.