Pedersen Pharmaceutical Chemical Analysis

Methods for Identification and Limit Tests
Erscheinungsjahr 2006
ISBN: 978-1-135-49281-6
Verlag: CRC Press
Format: EPUB
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 176 Seiten

Complete, referenced information in an easy-to-use format

Many of the monographs in the European Pharmacopiea, the industry standard test for certain groups of ingredients and excipients, do not describe the tests in full, but reference general methods based on test-tube chemistry. When a test fails, you need to know what went wrong, how it can be fixed, and how to convince QA\QC that the tested material is okay. This gives you little time to dig out the relevant scientific literature, literature that is often so old it doesn’t show up in an electronic search.

Making this knowledge easily accessible and directly applicable to work in the lab, Pharmaceutical Chemical Analysis: Methods for Limit Tests and Identifications explains the purpose of these older tests, the chemistry involved, and hazards to avoid. The book covers the identification of ions and functional groups tests and limit tests respectively. It covers subjects relevant to all the pharmacopoeial identification/limit test and then goes on to describe the individual tests in chapters organized and named as they appear in the European Pharmacopoeia. Each chapter begins with a short discussion on the purpose and rationale of the tests, followed by a review of the physical and chemical characters of the target ion or compound. The author describes the chemical background and logic of the individual procedural steps of the test with formulas and reaction and provides tips on the strengths and weaknesses of these techniques in terms of specificity, ruggedness, and potential procedural pitfalls.

Strict regulatory requirements and economic pressures make the pharmaceutical industry understandably reluctant to replace a test that is simple, cheap, and performs well with expensive, unvalidated instrumental techniques. This resource bridges the gap by providing an in-depth understanding of the principles behind the European Pharmacopoeia tests and how to use them, saving you valuable production time.

Zielgruppe

Pharmaceutical and analytical chemists, researchers and scientists performing target validation studies, and quality control laboratories.

Autoren/Hrsg.

Pedersen, Ole

Fachgebiete

• Naturwissenschaften Chemie Analytische Chemie
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizinische Fachgebiete Pharmakologie, Toxikologie

Inhaltsverzeichnis

Preface

Identifications

Precipitations
in Identifications

Color
reactions in identifications

Tests

Acetates
(European Pharmacopoeia 2.3.1)

Acetyl
(European Pharmacopoeia 2.3.1)

Alkaloids
(European Pharmacopoeia 2.3.1)

Aluminium
(European Pharmacopoeia 2.3.1)

Amines,
primary aromatic (European Pharmacopoeia
2.3.1)

Ammonium
salts (European Pharmacopoeia 2.3.1)

Ammonium
salts and salts of volatile bases (European Pharmacopoeia
2.3.1)

Antimony
(European Pharmacopoeia 2.3.1)

Arsenic
(European Pharmacopoeia 2.3.1)

Barbiturates,
non–nitrogen substituted (European Pharmacopoeia
2.3.1)

Benzoates
(European Pharmacopoeia 2.3.1)

Bismuth
(European Pharmacopoeia 2.3.1)

Bromides
(European Pharmacopoeia 2.3.1)

Calcium
(European Pharmacopoeia 2.3.1)

Carbonates
and bicarbonates (European Pharmacopoeia
2.3.1)

Chlorides
(European Pharmacopoeia 2.3.1)

Citrates
(European Pharmacopoeia 2.3.1)

Esters (European Pharmacopoeia
2.3.1)

Iodides (European Pharmacopoeia
2.3.1)

Iron (European Pharmacopoeia
2.3.1)

Lactates (European Pharmacopoeia
2.3.1)

Lead (European Pharmacopoeia
2.3.1)

Magnesium (European Pharmacopoeia
2.3.1)

Mercury (European Pharmacopoeia
2.3.1)

Nitrates (European Pharmacopoeia
2.3.1)

Phosphates (European Pharmacopoeia
2.3.1)

Potassium (European Pharmacopoeia
2.3.1)

Salicylates (European Pharmacopoeia
2.3.1)

Silicates (European Pharmacopoeia
2.3.1)

Silver (European Pharmacopoeia
2.3.1)

Sodium (European Pharmacopoeia
2.3.1)

Sulphates (European Pharmacopoeia
2.3.1)

Tartrates (European Pharmacopoeia
2.3.1)

Xanthines (European Pharmacopoeia
2.3.1)

Zinc
(European Pharmacopoeia 2.3.1)



Limit tests

Precipitations
in limit tests

Color
reactions in limit tests

Tests

Ammonium
(European Pharmacopoeia 2.4.1)

Arsenic
(European Pharmacopoeia 2.4.2)

Calcium
(European Pharmacopoeia 2.4.3)

Chlorides
(European Pharmacopoeia 2.4.4)

Fluorides
(European Pharmacopoeia 2.4.5)

Magnesium
(European Pharmacopoeia 2.4.6)

Magnesium and
alkaline-earth metals (European Pharmacopoeia
2.4.7)

Heavy metals
(European Pharmacopoeia 2.4.8)

Iron
(European Pharmacopoeia 2.4.9)

Phosphates
(European Pharmacopoeia 2.4.11)

Potassium
(European Pharmacopoeia 2.4.12)

Sulphates
(European Pharmacopoeia 2.4.13)

Sulphated ash
(European Pharmacopoeia 2.4.14)

Total ash
(European Pharmacopoeia 2.4.16)

Free
formaldehyde (European Pharmacopoeia
2.4.18)

Alkaline
impurities in fatty oils (European Pharmacopoeia
2.4.19)

About
the Author