By Lokesh Bhattacharyya, Jeffrey S. Rohrer
This can be a finished resource of knowledge at the software of ion chromatography (IC) within the research of pharmaceutical medicinal drugs and biologicals. This publication, with members from academia, pharma, the biotech undefined, and software production, offers the various views, adventure, and services of the concept leaders of IC in a finished demeanour. It explores power IC functions in several features of product improvement and quality controls checking out. moreover, an appendix part offers details on severe actual and chromatographic parameters concerning IC and knowledge on present brands of IC platforms, columns, and different components.Content:
Chapter 1 Ion Chromatography—Principles and functions (pages 1–21): Lokesh Bhattacharyya
Chapter 2 Retention tactics in Ion?Exclusion Chromatography: a brand new point of view (pages 23–47): Milko Novic and Paul R. Haddad
Chapter three Pulsed Electrochemical Detection in Ion Chromatography (pages 49–90): William R. Lacourse
Chapter four Suppressor layout and Detection for Ion Chromatography (pages 91–105): Kannan Srinivasan, Sheetal Bhardwaj, Rong Lin and Christopher Pohl
Chapter five Modelling and Optimization of Ion Chromatographic Separations of Pharmaceutically correct natural Ions (pages 107–133): Philip Zakaria, Greg Dicinoski, Melissa Hanna?Brown and Paul R. Haddad
Chapter 6 Ion Chromatography in Pharmaceutical Drug research (pages 135–157): Lokesh Bhattacharyya
Chapter 7 research for Impurities by means of Ion Chromatography (pages 159–174): Shreekant V. Karmarkar
Chapter eight Ion Chromatography research of Aminoglycoside Antibiotics (pages 175–192): Valoran P. Hanko and Jeffrey S. Rohrer
Chapter nine Use of Cation?Exchange Ion Chromatography within the research of prescribed drugs (pages 193–220): Christopher Pohl, Maria Rey and Rosanne Slingsby
Chapter eleven excessive functionality Ion Chromatographic research of Cholinergic Compounds: Carbachol and Bethanechol, and linked Degradation items (pages 237–245): David Trowbridge
Chapter 12 Ion Chromatographic research of prescribed drugs for Authenticity and Adulteration (pages 247–257): David S. Jackson
Chapter thirteen Ion Chromatography of Drug Product Counter?Ions and different Ions in Drug items (pages 259–269): Brian M. De Borba and Jeffrey S. Rohrer
Chapter 14 pattern instruction strategies in Ion Chromatography for Pharmaceutical functions (pages 271–283): Jay Gandhi
Chapter 15 Validation of Ion Chromatographic tools (pages 285–308): Shreekant V. Karmarkar
Chapter sixteen Pharmacopeial purposes of Ion Chromatography (pages 309–320): Ravi Ravichandran
Chapter 10 finished techniques for dimension of lively Pharmaceutical elements, Counter?Ions, and Excipients utilizing HPLC with Charged Aerosol Detection (pages 221–236): Christopher Crafts, Bruce Bailey, Paul Gamache, Xiaodong Liu and Ian Acworth
Chapter 17 Glycan research via excessive functionality Anion alternate Chromatography with Pulsed Amperometric Detection (pages 321–338): Lokesh Bhattacharyya
Chapter 18 Monosaccharide research of Glycoproteins by way of High?Performance Anion?Exchange Chromatography with Pulsed Amperometric Detection (pages 339–350): Jeffrey S. Rohrer
Chapter 19 Two?Dimensional Ion Chromatography for Simultaneous selection of Amino Acids and Carbohydrates (pages 351–364): Petr Jandik and Jun Cheng
Chapter 20 tracking Protein N?Glycosylation Consistency utilizing HPAEC?PAD (pages 365–377): Carl Grey
Chapter 21 Oligosaccharide research via High?Performance Anion?Exchange Chromatography Hyphenated to built-in Pulsed Amperometric Detection and On?Line Ion?Trap Mass Spectrometry (pages 379–391): Cees Bruggink
Chapter 22 purposes of Ion Chromatography in organic Product Analyses (pages 393–421): Alfred V. Del Grosso and Brandon Duong
Chapter 23 excessive functionality Anion?Exchange Chromatography with Pulsed Amperometric Detection (HPAEC?PAD) research of GBS Glycoconjugate Vaccines: From Fermentation to ultimate Product (pages 423–434): Stefano Ricci, Barbara Fabbri, Sara Giannini, Silvia Bernardini, Marcello Morelli and Sandro D'Ascenzi
Chapter 24 balance reviews and Characterization of Meningococcal A, C, Y, and W135 Glycoconjugate Vaccine (pages 435–447): Valeria Carinci, Alberto Bernardini, Cristiana Campa, Claudia Magagnoli, Francesca Beccai and Sandro D'Ascenzi
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Extra info for Applications of Ion Chromatography for Pharmaceutical and Biological Products
For simplicity, only IEC of anions is considered further in this chapter. That is, the stationary phase will be assumed to be a fully sulfonated resin. The current mechanism of IEC proposes that the sulfonate groups are ﬁxed mostly on the surface of the PS-DVB resin and form a negatively charged shield on the polymeric surface, often referred to as the “Donnan membrane”. The interior of the resin contains some occluded, or trapped, eluent, which is considered to act as the stationary phase. There is no general agreement regarding the precise morphology of this occluded eluent, but for the retention mechanism to be operative, this eluent liquid must be physically trapped within the polymer network and remain stationary.
In such a case, a negative or positive indirect UV/Vis signal can be expected if εHE ,λ − εE −λ < 0 or εHE ,λ − εE −,λ > 0 respectively. We can now consider published data for indirect detection in IEC using an aromatic acid as eluent, aliphatic acids as analytes, and a detection wavelength of 290 nm (at which the analytes show very little absorbance) . 12 shows the detector responses obtained by both conductivity and spectrophotometric detection with pyridinedicarboxylic acid (PDCA) as eluent.
Gjerde DT, Fritz JS, Schmuckler G. Anion chromatography with low-conductivity eluents. J. Chromatogr. 1979;186:509–519. 18. ICH Harmonised Tripartite Guideline. Validation of analytical procedures: text and methodology, Q2(R1). International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use, November 2005. 2 RETENTION PROCESSES IN ION-EXCLUSION CHROMATOGRAPHY: A NEW PERSPECTIVE Milko Novicˇ Faculty of Chemistry and Chemical Technology, Aˇskerˇceva, Ljubljana, Slovenia Paul R.