Isolation and characterization of degradation impurities in docetaxel drug substance and its formulation.
The degradation of docetaxel drug substance and its injection formulation has been investigated. The majority of impurities were observed in a base degradation study and all five degradation products were characterized. These impurities were isolated, enriched and were subjected to mass and NMR spectral studies. Based on the spectral data, these were characterized as 10-deacetyl baccatin III, 7-epi-10-deacetyl baccatin III, 7-epi-10-oxo-10-deacetyl baccatin III, 7-epi docetaxel and 7-epi-10-oxo-docetaxel, respectively. The last two impurities were also detected in the stability study of docetaxel formulation. Out of these degradation impurities two substances have been previously identified while the other three previously unreported.
Kumar
Dinesh
D
Analytical Laboratory-I, Dabur Research Foundation, 22, Site-IV, Sahibabad, Ghaziabad, Uttar Pradesh 201010, India. dineshk@dabur.com
Tomar
Rajesh Singh
RS
Deolia
Santosh Kumar
SK
Mitra
Moloy
M
Mukherjee
Rama
R
Burman
Anand C
AC
D000970:Antineoplastic Agents / Q000032:analysis* / Q000737:chemistry; D002851:Chromatography, High Pressure Liquid; D000077143:Docetaxel; D004340:Drug Contamination; D009682:Magnetic Resonance Spectroscopy; D013058:Mass Spectrometry; D015394:Molecular Structure; D043823:Taxoids / Q000032:analysis* / Q000737:chemistry
D000970:Antineoplastic Agents; D043823:Taxoids; D000077143:Docetaxel