Title:Genotoxic Impurities in Ranitidine Containing Products: An Overview
Volume: 7
Issue: 3
Author(s): Shailesh Bhosale, Kamal Kant, Divya Goyal and Anoop Kumar*
Affiliation:
- Department of Pharmacology and Toxicology, National Institute of Pharmaceutical Education and Research, Raebareli (NIPER-R) 226002, Lucknow (U.P.),India
Keywords:
Ranitidine, H2 blocker, genotoxic impurities, N-nitrosodimethylamine, pharmaceutical products.
Abstract: Ranitidine is a well known H2 blocker antihistaminic drug used for symptomatic relief
of heartburn, indigestion, acid indigestion, peptic ulcer and hyperacidity. However, On 13th September
2019, the United States Food and Drug Administration (USFDA) has given an alerting
statement regarding the presence of nitrosamine impurity called N-nitrosodimethylamine
(NDMA) in ranitidine containing products. Recently, some pharmaceutical companies have also
recalled their ranitidine containing products from the market. Thus, there is a need to understand
about these impurities in ranitidine containing products. The first part of this article highlights the
mechanism of action of ranitidine in established therapeutic indications along with its adverse
drug reactions and contraindications. Further, the introduction of genotoxic impurities in pharmaceutical
products along with its types and mechanism of toxicity of ranitidine containing genotoxic
impurity have been discussed.
