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 Technoljournal_title
Pharmaceutical development and technologyauthors
Stolarczyk EU,Kaczmarek L,Eksanow K,Kubiszewski M,Glice M,Kutner Adoi
10.1080/10837450802409388subject
Has Abstractpub_date
2009-01-01 00:00:00pages
27-37issue
1eissn
1083-7450issn
1097-9867pii
902918234journal_volume
14pub_type
杂志文章abstract::The physical stability of amorphous solid dispersions (SDs) is influenced by their storage conditions. The goal of this work was to investigate the factors affecting the recrystallization of drugs in SDs after storage under conditions of high temperature and high humidity. SDs of three drugs (dipyridamole, nifedipine ...
journal_title:Pharmaceutical development and technology
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journal_title:Pharmaceutical development and technology
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journal_title:Pharmaceutical development and technology
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journal_title:Pharmaceutical development and technology
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journal_title:Pharmaceutical development and technology
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journal_title:Pharmaceutical development and technology
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journal_title:Pharmaceutical development and technology
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journal_title:Pharmaceutical development and technology
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journal_title:Pharmaceutical development and technology
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journal_title:Pharmaceutical development and technology
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journal_title:Pharmaceutical development and technology
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journal_title:Pharmaceutical development and technology
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journal_title:Pharmaceutical development and technology
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journal_title:Pharmaceutical development and technology
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journal_title:Pharmaceutical development and technology
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journal_title:Pharmaceutical development and technology
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