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.
