IMPURITY PROFILING OF DRUGS TOWARDS SAFETY AND EFFICACY: THEORY AND PRACTICE

Last decade has witnessed enormous changes in the studies of impurity profiling of drugs which can be reflected from pharmacopoeia and regulatory guidelines. The present review article is an attempt to provide comprehensive knowledge about various aspects and details about the impurity profiling in...

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Autores principales:	DHANGAR,KIRAN R, JAGTAP,RAKESH B, SURANA,SANJAY J, SHIRKHEDKAR,ATUL A
Lenguaje:	English
Publicado:	Sociedad Chilena de Química 2017
Materias:	Impurity Profiling Regulatory guidelines Residual solvent Genotoxicity
Acceso en línea:	http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072017000200024
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spelling	oai:scielo:S0717-970720170002000242017-06-30IMPURITY PROFILING OF DRUGS TOWARDS SAFETY AND EFFICACY: THEORY AND PRACTICEDHANGAR,KIRAN RJAGTAP,RAKESH BSURANA,SANJAY JSHIRKHEDKAR,ATUL A Impurity Profiling Regulatory guidelines Residual solvent Genotoxicity Last decade has witnessed enormous changes in the studies of impurity profiling of drugs which can be reflected from pharmacopoeia and regulatory guidelines. The present review article is an attempt to provide comprehensive knowledge about various aspects and details about the impurity profiling in context with regulatory guidelines. Article also focused on isolation, separation and characterization techniques of impurities. It gives preliminary idea about applicability of virtual software used for studies on safety limit for impurities. The comprehensive information related to residual solvents, residual metals and genotoxicity studies of isolated impurities have also been incorporated into present article.info:eu-repo/semantics/openAccessSociedad Chilena de QuímicaJournal of the Chilean Chemical Society v.62 n.2 20172017-06-01text/htmlhttp://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072017000200024en10.4067/S0717-97072017000200024
institution	Scielo Chile
collection	Scielo Chile
language	English
topic	Impurity Profiling Regulatory guidelines Residual solvent Genotoxicity
spellingShingle	Impurity Profiling Regulatory guidelines Residual solvent Genotoxicity DHANGAR,KIRAN R JAGTAP,RAKESH B SURANA,SANJAY J SHIRKHEDKAR,ATUL A IMPURITY PROFILING OF DRUGS TOWARDS SAFETY AND EFFICACY: THEORY AND PRACTICE
description	Last decade has witnessed enormous changes in the studies of impurity profiling of drugs which can be reflected from pharmacopoeia and regulatory guidelines. The present review article is an attempt to provide comprehensive knowledge about various aspects and details about the impurity profiling in context with regulatory guidelines. Article also focused on isolation, separation and characterization techniques of impurities. It gives preliminary idea about applicability of virtual software used for studies on safety limit for impurities. The comprehensive information related to residual solvents, residual metals and genotoxicity studies of isolated impurities have also been incorporated into present article.
author	DHANGAR,KIRAN R JAGTAP,RAKESH B SURANA,SANJAY J SHIRKHEDKAR,ATUL A
author_facet	DHANGAR,KIRAN R JAGTAP,RAKESH B SURANA,SANJAY J SHIRKHEDKAR,ATUL A
author_sort	DHANGAR,KIRAN R
title	IMPURITY PROFILING OF DRUGS TOWARDS SAFETY AND EFFICACY: THEORY AND PRACTICE
title_short	IMPURITY PROFILING OF DRUGS TOWARDS SAFETY AND EFFICACY: THEORY AND PRACTICE
title_full	IMPURITY PROFILING OF DRUGS TOWARDS SAFETY AND EFFICACY: THEORY AND PRACTICE
title_fullStr	IMPURITY PROFILING OF DRUGS TOWARDS SAFETY AND EFFICACY: THEORY AND PRACTICE
title_full_unstemmed	IMPURITY PROFILING OF DRUGS TOWARDS SAFETY AND EFFICACY: THEORY AND PRACTICE
title_sort	impurity profiling of drugs towards safety and efficacy: theory and practice
publisher	Sociedad Chilena de Química
publishDate	2017
url	http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072017000200024
work_keys_str_mv	AT dhangarkiranr impurityprofilingofdrugstowardssafetyandefficacytheoryandpractice AT jagtaprakeshb impurityprofilingofdrugstowardssafetyandefficacytheoryandpractice AT suranasanjayj impurityprofilingofdrugstowardssafetyandefficacytheoryandpractice AT shirkhedkaratula impurityprofilingofdrugstowardssafetyandefficacytheoryandpractice
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IMPURITY PROFILING OF DRUGS TOWARDS SAFETY AND EFFICACY: THEORY AND PRACTICE

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