Preface ......................................................... v
Editors ....................................................... vii
Contributors ................................................... ix
Introduction ................................................... xi
Chapter 1 Purity Analysis and Impurities Determination by
Reversed-Phase High-Performance Liquid
Chromatography ....................................... 1
Hagen Cramer, Kevin J. Finn, and Eric Herzberg
Chapter 2 Purity Analysis and Impurities Determination by
AEX-HPLC ............................................ 47
Jim Thayer, Veeravagu Murugaiah, and Yansheng Wu
Chapter 3 Purity Analysis and Molecular Weight
Determination by Size Exclusion HPLC ............... 105
Ming Fai Chan and Ipsita Roymoulik
Chapter 4 Analysis of Oligonucleotides by Liquid
Chromatography and Mass Spectrometry ............... 137
Soheil Pourshahian and Sean M. McCarthy
Chapter 5 Sequence Determination and Confirmation by MS/MS
and MALDI-TOF ...................................... 167
Zoltan Timar
Chapter 6 Tm Analysis of Oligonucleotides .................... 219
Huihe Zhu and G. Susan Srivatsa
Chapter 7 Purity and Content Analysis of Oligonucleotides
by Capillary Gel Electrophoresis ................... 243
Judy Carmody and Bernhard Noll
Chapter 8 Bioanalysis of Therapeutic Oligonucleotides
Using Hybridization-Based Immunoassay
Techniques ......................................... 265
Helen Legakis and Sandra Carriero
Chapter 9 Oligonucleotide Assay and Potency .................. 285
Dennis P. Michaud
Chapter 10 Microbial Analysis: Endotoxin Testing .............. 307
Barbara J. Markley
Chapter 11 Analysis of Residual Solvents by Head Space Gas
Chromatography ..................................... 331
Sky Countryman and Jose V. Bonilla
Chapter 12 Determination of Extinction Coefficient ............ 351
Veeravagu Murugaiah
Chapter 13 Structural Determination by NMR .................... 361
Michele L. DeRider, Doug Brooks, and Gary Burt
Chapter 14 Infrared Analysis of Oligonucleotides .............. 385
Jose V. Bonilla
Chapter 15 Stability Indicating Methods for Oligonucleotide
Products ........................................... 403
Veeravagu Murugaiah
Chapter 16 Analysis by Hydrophilic Interaction
Chromatography ..................................... 425
Renee N. Easter and Patrick A. Limbach
Chapter 17 Determination of Base Composition .................. 439
Hüseyin Aygün
Chapter 18 Analysis of Metals in Oligonucleotides ............. 453
Michael P. Murphy
Chapter 19 Regulatory Considerations for the Development of
Oligonucleotide Therapeutics ....................... 465
G. Susan Srivatsa
Index ......................................................... 487
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