Identification and characterization of potential impurities of quetiapine fumarate.

Abstract:

:Seven potential impurities, including by-products, starting materials and intermediates were identified in pharmaceutical substance quetiapine fumarate and characterized by spectroscopic methods (MS, IR, NMR). Based on these methods the structures of the impurities were assigned or confirmed as: impurity I: 2-(phenylthio)aniline; impurity II: phenyl N-[2-(phenylthio)phenyl]carbamate; impurity III: N,N'-bis[2-(phenylthio) phenyl]urea; impurity IV: N-[2-(phenylthio)phenyl]-1-piperazinecarboxamide hydrochloride; impurity V: N,N'-bis[(2-phenylthio)phenyl]-1,4-piperazinedicarboxamide; impurity VI: 11-(1-piperazinyl) dibenzo[b,f][1,4]thiazepine fumarate; impurity VII: 1,4-bis(dibenzo[b,f][1,4] thiazepin-11-yl)piperazine. Structural elucidation of compounds, proposed MS fragmentation pathway and possible ways of formation of the impurities are also discussed.

journal_name

Pharm Dev Technol

authors

Stolarczyk EU,Kaczmarek L,Eksanow K,Kubiszewski M,Glice M,Kutner A

doi

10.1080/10837450802409388

subject

Has Abstract

pub_date

2009-01-01 00:00:00

pages

27-37

issue

1

eissn

1083-7450

issn

1097-9867

pii

902918234

journal_volume

14

pub_type

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