Book description
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.
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 PhD 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 PhD in analytical
chemistry from Purdue University under the direction of Professor R.
Graham Cooks.
