Forced degradation and impurity profiling: Recent trends in analytical perspectives

Jain, Deepti; Basniwal, Pawan K

doi:10.1016/j.jpba.2013.07.013

Cited by 139 publications

(58 citation statements)

References 196 publications

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“…Forced degradation studies provide data to support identification of possible degradants; degradation pathways and intrinsic stability of the drug molecule and validation of stability indicating analytical procedures [8]. Hitherto, as per knowledge of authors, there is no forced degradation studies have been reported in literature including degradation pathway and intrinsic pathway of AMD.…”

Section: Introductionmentioning

confidence: 99%

Intrinsic Stability Study of Armodafinil Hydrochloride by Forced Degradation and Impurity Profiling

Jain¹,

Basniwal²

2015

Pharm Anal Acta

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Objective: A novel RP-HPLC-DAD-HRMS method was developed for determination of armodafinil in presence of related substances viz. impurities and forced degradation products and its intrinsic stability was established by forced degradation profiling.Method: Armodafinil and its degradation products were successfully separated on Zorbax Eclipse Plus C18 column (250 × 4.6 mm, 5 μm) by mixture of 0.1% formic acid and acetonitrile (in gradient mode) at 1 ml/min flow rate within 20 min and detection was performed by photodiode-array detector at 252 nm.Results: Drug was extensively degraded in alkaline conditions followed by acidic and neutral conditions, while there was no degradation observed in thermal, oxidative and ultra-violet degradation conditions. Only one impurity (AMD-Imp) was identified as phenylmethanesulfinic acid. Structure of degradation products and degradation pathways of drug have been postulated for hydrolytic condition.

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Section: Introductionmentioning

confidence: 99%

Intrinsic Stability Study of Armodafinil Hydrochloride by Forced Degradation and Impurity Profiling

Jain¹,

Basniwal²

2015

Pharm Anal Acta

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“…Stability studies and profiling of product and process-related impurities are required by local regulatory authorities and should be monitored not only during production and batch release but also in postmarketing surveillance studies [11,14,15,23].…”

Section: Introductionmentioning

confidence: 99%

Assessment of the Effects of Glycosylation on the Pattern and Kinetics of Degradation of Lenograstim in Comparison to Filgrastim Using a Stability-Indicating Orthogonal Testing Protocol

et al. 2015

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“…Selection of an oxidizing agent, its concentration, and conditions depends on the drug substance. [1,30] [31]…”

Section: Oxidation Conditionsmentioning

confidence: 99%

An Updated Review: Forced Degradation Study

Srivastavá¹

2017

WJPPS

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Forced degradation is a powerful tool used routinely in pharmaceutical development in order to develop the stability indicating methods that lead to quality stability data and to understand the degradation pathways of the drug substances and drug products. The study ensures the appropriate stability of final pharmaceutical products in very early stages of pharmaceutical development. The forced degradation study is an essential step in the design of a regulatory compliant stability program for drug and formalized as a regulatory requirement. Thus, this review discusses the current trends in performance of forced degradation studies by providing a strategy for conducting studies on degradation mechanisms and also describes the analytical methods helpful for the development of stability indicating method.

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Forced degradation and impurity profiling: Recent trends in analytical perspectives

Cited by 139 publications

References 196 publications

Intrinsic Stability Study of Armodafinil Hydrochloride by Forced Degradation and Impurity Profiling

Intrinsic Stability Study of Armodafinil Hydrochloride by Forced Degradation and Impurity Profiling

Assessment of the Effects of Glycosylation on the Pattern and Kinetics of Degradation of Lenograstim in Comparison to Filgrastim Using a Stability-Indicating Orthogonal Testing Protocol

An Updated Review: Forced Degradation Study

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