Identification of major impurities in doxofylline injection / 中国药学杂志
Chinese Pharmaceutical Journal
;
(24): 334-337, 2014.
Article
in Chinese
| WPRIM
| ID: wpr-859840
ABSTRACT
OBJECTIVE:
To identify the structures of the major impurities of doxofylline injection.METHODS:
HPLC-QTOF-MS was adopted to analyze the structures of two major impurities; the impurities were further separated and prepared by prep-HPLC and the structures were elucidated by NMR spectral data.RESULTS:
The two major impurities were elucidated as 7-(2', 2'-dihydroxy ethyl) theophylline and 9-(1, 3-dioxolan-2-ylmethyl) theophylline.CONCLUSION:
The two major impurities are thermo-degradation impurity and process related impurity respectively. This study provides reference for the improvement of quality control and process optimization of doxofylline injection.
Full text:
Available
Index:
WPRIM (Western Pacific)
Type of study:
Diagnostic study
Language:
Chinese
Journal:
Chinese Pharmaceutical Journal
Year:
2014
Type:
Article
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