Quantification of residual EDU (N-ethyl-N'-(dimethylaminopropyl) carbodiimide (EDC) hydrolyzed urea derivative) and other residual by LC-MS/MS.
An LC-MS/MS method for determination of the break down product of N-ethyl-N'-(3-dimethylaminopropyl) carbodiimide (EDC) urea derivative, EDU, has been developed and validated for monitoring the residual coupling reagents. Results indicate that the method exhibits suitable specificity, sensitivity, precision, linearity and accuracy for quantification of residual EDU in the presence of meningococcal polysaccharide-diphtheria toxoid conjugate vaccine and other vaccine matrix compounds. The assay has been validated for a detection range of 10-100 ng/mL and then successfully transferred to quality control (QC) lab. This same method has also been applied to the determination of residual diaminohexane (DAH) in the presence of EDU. LC-MS/MS has proven to be useful as a quick and sensitive approach for simultaneous determination of multiple residual compounds in glycoconjugate vaccine samples.
Lei
Q Paula
QP
Analytical Science and Assay Development, Aventis Pasteur, Discovery Drive, Swiftwater, PA 18370, USA. paula.lei@aventis.com
Lamb
David H
DH
Shannon
Anthony G
AG
Cai
Xinxing
X
Heller
Ronald K
RK
Huang
Michael
M
Zablackis
Earl
E
Ryall
Robert
R
Cash
Patricia
P
D002138:Calibration; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D005022:Ethyldimethylaminopropyl Carbodiimide / Q000031:analogs & derivatives* / Q000032:analysis*; D006868:Hydrolysis; D013058:Mass Spectrometry / Q000379:methods*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
C041829:1-ethyl-3-(3-(dimethylamino)propyl)carbodiimide methiodide; D005022:Ethyldimethylaminopropyl Carbodiimide