Introduction

Riley, Christopher M.; Mueller, Bradford J.; Rosanske, Thomas W.; Riley, Shelley R. Rabel

doi:10.1016/b978-0-08-098350-9.00001-1

Specification of Drug Substances and Products 2014

DOI: 10.1016/b978-0-08-098350-9.00001-1

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Introduction

Christopher M. Riley¹,

Bradford J. Mueller

Thomas W. Rosanske³

et al.

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2017

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“…Many analytical techniques are used for separation of impurities and characterization of it [103][104][105][106]. [107][108][109] A general scheme is set up for the estimation of the impurity profile of benzazepine-2,3-dione. 120…”

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confidence: 99%

Impurity Profiling of Drugs Towards Safety and Efficacy: Theory and Practice

Dhangar

Jagtap

Surana

et al. 2017

J. Chil. Chem. Soc.

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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.

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mentioning

confidence: 99%

Impurity Profiling of Drugs Towards Safety and Efficacy: Theory and Practice

Dhangar

Jagtap

Surana

et al. 2017

J. Chil. Chem. Soc.

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show abstract

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Introduction

Cited by 1 publication

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Impurity Profiling of Drugs Towards Safety and Efficacy: Theory and Practice

Impurity Profiling of Drugs Towards Safety and Efficacy: Theory and Practice

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