Genotoxic Impurities in Ranitidine Containing Products: An Overview

Author(s): Shailesh Bhosale, Kamal Kant, Divya Goyal, Anoop Kumar*

Journal Name: Applied Clinical Research, Clinical Trials and Regulatory Affairs
Continued as Applied Drug Research, Clinical Trials and Regulatory Affairs

Volume 7 , Issue 3 , 2020

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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.

Keywords: Ranitidine, H2 blocker, genotoxic impurities, N-nitrosodimethylamine, pharmaceutical products.

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Article Details

VOLUME: 7
ISSUE: 3
Year: 2020
Published on: 24 December, 2020
Page: [155 - 161]
Pages: 7
DOI: 10.2174/2213476X07666200423081738
Price: $25

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