The book highlights the current practices and future trends in
structural characterization of impurities and degradants. It begins
with an overview of mass spectrometry techniques as related to the
analysis of impurities and degradants, followed by studies
involving characterization of process related impurities (including
potential genotoxic impurities), and excipient related impurities
in formulated products. Both general practitioners in
pharmaceutical research and specialists in analytical chemistry
field will benefit from this book that will detail step-by-step
approaches and new strategies to solve challenging problems related
to pharmaceutical research.
关于作者
BIRENDRA N. PRAMANIK is a Distinguished Fellow at Merck
Research Laboratories, where he directs spectroscopy programs
covering mass spectrometry and NMR efforts. He was previously a
distinguished fellow at Schering-Plough Research Institute. He
received his Ph D in organic chemistry under the late Professor Ajay
K. Bose from Stevens Institute of Technology in 1977.
MIKE S. LEE is President of Milestone Development
Services, a provider of consulting services specializing in
pharmaceutical analysis and accelerated drug discovery and
development strategies in Newtown, Pennsylvania. He previously
directed program research at Bristol-Myers Squibb, Pharmaceutical
Research Institute in New Brunswick, New Jersey.
GUODONG CHEN is Principal Scientist in Bioanalytical and
Discovery Analytical Sciences at Bristol-Myers Squibb in Princeton,
New Jersey. He heads a mass spectrometry group in support of drug
discovery as well as development programs in small molecule
pharmaceuticals and biologics. He received his Ph D in analytical
chemistry from Purdue University under the direction of Professor
R. Graham Cooks.
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