A REVIEW ON NITROSAMINE IMPURITY- SOURCES, ANALYTICAL METHODS, CARCINOGENICITY AND PRESENCE IN VARIOUS DRUGS

The presence of N-nitrosamines in pharmaceutical products has caused concern among health regulators and pharmaceutical companies. When nitrates or nitrites react with amines, nitrosamines are formed. Nitrosamines and/or their precursors are present in a variety of consumer items. Some sartan pharmaceutical products were discovered to be contaminated with nitrosamine compounds, which are very carcinogenic. Special emphasis was paid to N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA). The most prevalent Nitrosamines detected are NDMA and NDEA, however there are numerous more Nitrosamines as well. Certain nitrosamines may increase the risk of cancer if people are exposed to them at higher-than-safe levels for an extended period of time.  People who consummate NDMA-containing drugs at or below the permissible consumption limits on a daily basis for 70 years are unlikely to get cancer. They can be present in medications, cosmetics, water, and food. Many variables contribute to the development of N-nitrosamine. The Food and Drug Administration classifies two Tobacco Specific Nitrosamines (TSNA) as dangerous and potentially harmful components (HPHCs) in tobacco products and tobacco, N-nitrosonornicotine (NNN) and 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK). Many approaches for detecting nitrosamine have been developed since 1954.

Keywords: Nitrosamine; NNK; NDMA; NDE; NNN; TSNA