Analytical profiles of drug substances Volume 03

Medical Ebook
PREFACE

Although the official compendia list tests and limits for drug substances
related t o identity, purity, and strength, they normally do not provide other
physical or chemical data, nor do they list methods of synthesis or pathways
of physical or biological degradation and metabolism. For drug substances
important enough to be accorded monographs in the official compendia such
supplemental information should also be made readily available. To this end
the Pharmaceutical Analysis and Control Section, Academy of Pharmaceutical
Sciences, has undertaken a cooperative venture t o compile and publish
Analytical Profiles of Drug Substances in a series of volumes of which this
is the third.

Reviews and comments received so far have reinforced our belief that
the series fills a need and they have strengthened our determination to continue.
The enthusiasm and cooperative spirit of our contributors have made
these profiles possible. All those who have found the profiles useful are
earnestly requested t o contribute a monograph of their own. The editors
stand ready to receive such contributions.
Beginning with Volume 2 a cumulative index has been added, t o facilitate
the correction of errors and t o encourage the addition or relevant new
information.

The concept of analytical profiles is taking hold not only for compendial
drugs but, increasingly, in the industrial research laboratories. Analytical
profiles are being prepared and periodically updated t o provide
physico-chemical and analytical information on new drug substances during
the consecutive stages of research and development. Hopefully then, in the
not too distant future, the publication of an analytical profile will require
a minimum of effort whenever a new drug substance is selected for compendial
status.

Klaus Florey

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