A multidisciplinary approach to identify a degradation product in a pharmaceutical dosage form

被引：7
|
作者：
Pan, Changkang [1 ]
Guan, Jack [2 ]
Lin, Melissa [1 ]
机构：
[1] Novartis Pharmaceut, E Hanover, NJ 07936 USA
[2] Sandoz Dev Ctr, E Hanover, NJ 07936 USA
来源：
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS | 2011年 / 54卷 / 04期
关键词：
Pharmaceutical impurity identification; Tandem MS; TOF MS; NMR; Excipient degradation; IDENTIFICATION; LC/MS; ACID;
D O I：
10.1016/j.jpba.2010.10.016
中图分类号：
O65 [分析化学];
学科分类号：
070302 ; 081704 ;
摘要：
An unknown degradation product found in non-MS compatible HPLC analysis was studied using a multidisciplinary approach. The unknown was separated and isolated from other components in the drug product by HPLC followed by ion trap MS to obtain MSn fragmentation patterns. Its chemical formula was determined using a high resolution time-of-flight mass spectrometer (TOF MS). Nuclear Magnetic Resonance (NMR) was used to elucidate the molecular structure. The impurity was identified as 5-hydroxymethyl furfural, which was a degradation product of lactose, one of the excipients used in the formulation of this dosage form. (C) 2010 Elsevier B.V. All rights reserved.
引用
收藏
页码：855 / 859
页数：5
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