UGC Approved Journal no 63975(19)

ISSN: 2349-5162 | ESTD Year : 2014
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Published in:

Volume 4 Issue 12
December-2017
eISSN: 2349-5162

UGC and ISSN approved 7.95 impact factor UGC Approved Journal no 63975

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Published Paper ID:
JETIR1712188


Registration ID:
230978

Page Number

49-67

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Title

N-nitrosodimethylamine Genotoxic impurity in Valsartan products and its analytical methods for determination of NDMA .

Abstract

In Valsartan drug products impurity have been found such as N-nitrosodimethylamine (NDMA) which is Carcinogenic in nature and also produce toxic effect to the Human being and also to the animals ,so that action taken by the regulatory agencies .batch recalls for valsartan containing drugs products in July 2018 .It was found that NDMA was produced during synthesis of API means active pharmaceutical ingredient from the reagent nitrite and solvents dimethylformamide. This review summarizes various methods for determination of NDMA these are HPLC-MS/MS, Liquid chromatography /mass spectroscopy ,High resolution LC-MS/MS ,GC-MS/MS .also this review focus on valsartan synthesis routes ,properties , valsartan recalls ,NDMA risk assessment tools ,ICH M7 guidelines ,Valsartan impurity profiling .

Key Words

NDMA N-nitrosodimethylamine ,recalls ,carcinogenic ,risk assessment ,ICH M7guidelines ,valsartan synthesis route .

Cite This Article

"N-nitrosodimethylamine Genotoxic impurity in Valsartan products and its analytical methods for determination of NDMA .", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.4, Issue 12, page no.49-67, December-2017, Available :http://www.jetir.org/papers/JETIR1712188.pdf

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2349-5162 | Impact Factor 7.95 Calculate by Google Scholar

An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 7.95 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator

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"N-nitrosodimethylamine Genotoxic impurity in Valsartan products and its analytical methods for determination of NDMA .", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.4, Issue 12, page no. pp49-67, December-2017, Available at : http://www.jetir.org/papers/JETIR1712188.pdf

Publication Details

Published Paper ID: JETIR1712188
Registration ID: 230978
Published In: Volume 4 | Issue 12 | Year December-2017
DOI (Digital Object Identifier): http://doi.one/10.1729/Journal.23612
Page No: 49-67
Country: Ahmednagar, Maharashtra, India .
Area: Pharmacy
ISSN Number: 2349-5162
Publisher: IJ Publication


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