Literature DB >> 21193280

Strategies for the identification, control and determination of genotoxic impurities in drug substances: a pharmaceutical industry perspective.

N V V S S Raman1, A V S S Prasad, K Ratnakar Reddy.   

Abstract

Regulations alarmed the control of genotoxic impurities in drug substances at lower level based on the threshold of toxicological concern and daily dose. This review explores the details of various regulations and guidances, toxicology assessment, identification of structural alerts, synthetic origins, different synthetic approaches for elimination or control, various analytical determination strategies and pharmaceutical industry concern towards genotoxic impurities.
Copyright © 2010 Elsevier B.V. All rights reserved.

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Year:  2010        PMID： 21193280     DOI： 10.1016/j.jpba.2010.11.039

Source DB:  PubMed          Journal:  J Pharm Biomed Anal        ISSN： 0731-7085            Impact factor:   3.935


  7 in total

1.  Development of GC-MS/MS Method for Simultaneous Estimation of Four Nitrosoamine Genotoxic Impurities in Valsartan.

Authors:  Sambasiva Rao Tummala; Krishnamanjari Pawar Amgoth
Journal:  Turk J Pharm Sci       Date:  2022-08-31

2.  Trace Level Quantification of the (-)2-(2-amino-5-chlorophenyl)-4-cyclopropyl-1,1,1-trifluoro-3-butyn-2-ol Genotoxic Impurity in Efavirenz Drug Substance and Drug Product Using LC-MS/MS.

Authors:  Nagadeep Jaishetty; Kamaraj Palanisamy; Arthanareeswari Maruthapillai; Rajamanohar Jaishetty
Journal:  Sci Pharm       Date:  2015-10-18

3.  Determination of genotoxic alkyl methane sulfonates and alkyl paratoluene sulfonates in lamivudine using hyphenated techniques.

Authors:  N V V S S Raman; A V S S Prasad; K Ratnakar Reddy; K Ramakrishna
Journal:  J Pharm Anal       Date:  2012-03-14

4.  In vitro toxic evaluation of two gliptins and their main impurities of synthesis.

Authors:  Camila F A Giordani; Sarah Campanharo; Nathalie R Wingert; Lívia M Bueno; Joanna W Manoel; Barbara Costa; Shanda Cattani; Marcelo Dutra Arbo; Solange Cristina Garcia; Cássia Virginia Garcia; Nádia Maria Volpato; Elfrides Eva Scherman Schapoval; Martin Steppe
Journal:  BMC Pharmacol Toxicol       Date:  2019-12-19       Impact factor: 2.483

5.  Analytical Method Development for 19 Alkyl Halides as Potential Genotoxic Impurities by Analytical Quality by Design.

Authors:  Kyoungmin Lee; Wokchul Yoo; Jin Hyun Jeong
Journal:  Molecules       Date:  2022-07-11       Impact factor: 4.927

6.  Direct detection of a sulfonate ester genotoxic impurity by atmospheric-pressure thermal desorption-extractive electrospray-mass spectrometry.

Authors:  Neil A Devenport; Laura C Sealey; Faisal H Alruways; Daniel J Weston; James C Reynolds; Colin S Creaser
Journal:  Anal Chem       Date:  2013-06-21       Impact factor: 6.986

7.  Development and Validation of LC-MS/MS for Analyzing Potential Genotoxic Impurities in Pantoprazole Starting Materials.

Authors:  Yuyuan Chen; Song Wu; Qingyun Yang
Journal:  J Anal Methods Chem       Date:  2020-03-09       Impact factor: 2.193
  7 in total

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