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1627701 
Journal Article 
Isolation and analysis of trace level of silicone oil in pharmaceutical bulk drug substance by ICP-AES 
Jia, XJ; Wang, TB; Bu, XD; Wu, J 
2003 
1 
Microchemical Journal
ISSN: 0026-265X
EISSN: 1095-9149 
75 
2 
103-107 
WOS:000185912500005 
In order to evaluate the extent of silicone oil
contamination in a drug substance derived from processing equipment, a novel extraction method
was developed which uses a mixture of polar and non-polar solvents (toluene/acetonitrile). Unlike
the majority of silicone oil extraction methods in the literature that yield very low recoveries,
this procedure proved able to completely recover the silicone oil from this compound. The
recovered silicone oil was rediluted in isopropanol alcohol (IPA)/toluene mixture and
subsequently analyzed by an inductively coupled plasma atomic emission spectrometer (ICP-AES)
coupled to an ultrasonic nebulizer (USN). (C) 2003 Elsevier Science B.V. All rights reserved. 
silicone oil; extraction; drug substance; inductively coupled plasma atomic emission spectrometry (ICP-AES)