This edition first published 2019
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Edition history:
“John Wiley & Sons Ltd. (1e, 2012)”.
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Library of Congress Cataloging‐in‐Publication Data
Names: Pedersen-Bjergaard, Stig, author. | Gammelgaard, Bente, author. |
Halvorsen, Trine G. (Trine Grønhaug), 1975- author.
Title: Introduction to pharmaceutical analytical chemistry / Stig
Pedersen-Bjergaard, Department of Pharmacy, University of Oslo, Norway and
Department of Pharmacy, University of Copenhagen, Denmark, Bente
Gammelgaard, Department of Pharmacy, University of Copenhagen,
Denmark,Trine Grønhaug Halvorsen, Department of Pharmacy, University of Oslo,
Norway.
Other titles: Introduction to pharmaceutical chemical analysis.
Description: Second edition. | Hoboken, NJ : Wiley, 2019. | Revision of:
Introduction to pharmaceutical chemical analysis / Steen Hansen, Stig
Pedersen-Bjergaard, Knut Rasmussen. 2012. | Includes bibliographical
references and index. |
Identifiers: LCCN 2018051420 (print) | LCCN 2018053744 (ebook) | ISBN
9781119362722 (Adobe PDF) | ISBN 9781119362753 (ePub) | ISBN 9781119362722
(paperback)
Subjects: LCSH: Drugs–Analysis. | Pharmaceutical chemistry. | BISAC: SCIENCE
/ Chemistry / Analytic.
Classification: LCC RS189 (ebook) | LCC RS189 .H277 2019 (print) | DDC
615.1/9–dc23
LC record available at https://lccn.loc.gov/2018051420
Cover design: Wiley
This textbook is an extensive revision of ‘Introduction to Pharmaceutical Analysis’ from 2012. We have revised the manuscript totally, and updated the content according to current practice in pharmaceutical analytical chemistry, and according to current versions of European and United States Pharmacopeia. Additionally, we have added a new chapter on chemical analysis of biopharmaceuticals, improved the illustrations throughout and provided illustrations in colour. The intention of these efforts has been to provide the reader with a textbook at the level expected in 2018.
We have changed the title to emphasize that this textbook is about analytical chemistry, and that the applications described are all related to pharmaceuticals. However, the philosophy is the same as with the first edition. The textbook is primarily for pharmacy and chemistry students (and other scientists approaching the pharmaceutical sciences) at university level, requesting basic knowledge on chemical analysis of pharmaceutical ingredients and preparations, and chemical analysis of drug substances in biological fluids. In the first part of the textbook, we teach the fundamentals of the main analytical techniques. Compared to textbooks in pure analytical chemistry, we go into less detail but we still teach to a level where the reader can understand the details in current pharmacopeia and bioanalytical methods. The second part of the textbook is unique, as we focus on identification, purity testing and assay of pharmaceutical ingredients, identification and quantitation of active ingredients in pharmaceutical preparations, and identification and quantitation of drugs in biological fluids. Such systematic discussion of pharmaceutical applications is not found in any other textbook on the market.
Originally, this textbook was written in Norwegian by Stig Pedersen‐Bjergaard and Knut Rasmussen. The first Norwegian edition came in 2004 (ISBN 82‐7674‐844‐9), and this was revised in 2010 (ISBN 978‐82‐450‐1013‐8). The manuscript was translated to English and improved by Stig Pedersen‐Bjergaard, Knut Rasmussen, and Steen Honoré Hansen in 2012. Since that first English edition, the author team has changed. Knut Rasmussen has retired and Steen Honoré Hansen passed away in the autumn 2017. Knut is acknowledged for his pioneering work in the period 2004–2012, and for his highly valuable advice during preparation of the current edition. Steen is acknowledged for his work on translation and improvements in preparation of the first English edition of the book, and the valuable discussions of the content and improvements of the present edition until autumn 2017. We also thank our colleagues and students at the University of Oslo and the University of Copenhagen for inspiration, discussions, advice, proof reading, chromatograms, titration curves, and fun.
Oslo/Copenhagen, June 2018
Stig Pedersen‐Bjergaard Bente Gammelgaard Trine Grønhaug Halvorsen
University of Oslo University of Copenhagen University of Oslo
University of Copenhagen
The units in the book do not strictly follow the SI units. The units are adjusted to the dimensions in analytical work.
| Symbol | Unit | |
| A | Absorbance | — |
| A(1%, 1 cm) | Specific absorbance | — |
| AS | Symmetry factor | — |
| a | Activity | — |
| α | Relative retention (separation factor) | — |
 |
Specific optical rotation | (°) degrees |
| c | Concentration | g/L, mol/L |
| d | Dextrorotary (optical rotation) | ° (degrees) |
| D | Distribution ratio (also named distribution coefficient or partition coefficient) | — |
| E | Potential | V |
| E | Electrical field (CE) | V/cm |
| E0 | Standard electrode potential (standard reduction potential) | V |
| ε | Molar absorption coefficient | cm−1 · mol−1 · L |
| εo | Relative elution strength | — |
| η | Viscosity | cPoise |
| F | Flow rate (chromatography) | mL/min |
| F | Fluorescence | — |
| h | Peak height | mm |
| H | Height equivalent to theoretical plate | |
| I | Intensity | — |
| IA | Acid value | mg |
| II | Iodine value | mg |
| IOH | Hydroxyl value | mg |
| IS | Saponification value | mg |
| Ka | Acid ionization constant (= acid dissociation constant, acidity constant) | M |
| Kb | Base ionization constant (= basicity constant) | M |
| KD | Partition ratio (= distribution constant) | |
| Kw | Autoprotolysis equilibrium constant of water (= ion product of water) | M2 |
| k | Retention factor | — |
| λ | Wavelength | nm |
| L | Length | m (mm) |
| l | Levorotary (optical rotation) | ° (degrees) |
| μapp | Apparent mobility | cm2 · min−1 · V−1 |
| μe | Electrophoretic mobility | cm2 · min−1 · V−1 |
| μeo | Electroosmotic mobility | cm2 · min−1 · V−1 |
| M | Molarity | mol /L−1 |
| M | Molar mass | g/mol |
| M | Molecular mass | u = Da |
| Mr | Relative molar mass | — |
| N | Number of theoretical plates | — |
| ν | Frequency | Hz (s−1) |
| pI | Isoelectric point | — |
| P | Distribution ratio between 1‐octanol and aqueous solution, pH 7.4 | — |
| P′ | Polarity index | — |
| φ | Quantum yield (fluorescence) | — |
| r | Radius | m (mm) |
| Rf | Retention factor (TLC) | — |
| RS | Resolution (chromatography) | — |
| ρ | Density | g/cm3 |
| σ | Standard deviation | — |
| s | Standard deviation | |
| T | Temperature | K, C |
| T | Transmittance | — |
| tR | Retention time | min |
| tM | Hold‐up time | min |
| t′R | Adjusted retention time | min |
| u | Linear velocity (flow rate) | cm/s |
| v | Velocity | m/s |
| V | Volume | L, 1 mL = 1 cm3 |
| VM | Hold‐up volume (void volume) (LC); total permeation volume (SEC) | mL |
| VO | Exclusion volume | mL |
| VR | Retention volume | mL |
| W | Peak width | min |
| Wh | Peak width at half height | min |
|
Mean | — |
| z | Charge | — |
| Avogadro's number | N | 6.0221 × 1023 mol−1 |
| Faraday's constant | F | 9.649 × 104 · C(oulomb) · mol−1 = 96.485 kJ · mol−1 |
| Gas constant | R | 8.314 J · K−1 · mol−1 |
| Speed of light in vacuum | c | 2.998 × 108 m/s |
| Planck's constant | h | 6.626 × 10−34 J · s |
| ln(loge) = log10 × 2.303 | ||
| Upper case | Lower case | Name | English |
| A | α | Alpha | a |
| B | β | Beta | b |
| Γ | γ | Gamma | g |
| Δ | δ | Delta | d |
| E | ɛ | Epsilon | e |
| Z | ζ | Zeta | z |
| H | η | Eta | h |
| Θ | θ | Theta | th |
| I | ι | Iota | i |
| K | κ | Kappa | k |
| Λ | λ | Lambda | l |
| M | μ | Mu | m |
| N | ν | Nu | n |
| Ξ | ξ | Xi | x |
| O | o | Omicron | o |
| Π | π | Pi | p |
| P | ρ | Rho | r |
| Σ | σ, ς * | Sigma | s |
| T | τ | Tau | t |
| Y | υ | Upsilon | u |
| Φ | φ | Phi | ph |
| X | χ | Chi | ch |
| Ψ | ψ | Psi | ps |
| Ω | ω | Omega | o |