Analytical Profiles of Drug Substances Volume 10 (Analytical Profiles of Drug Substances and Excipients)

Medical Ebook

PREFACE

Although the official compendia list tests and limits for drug substances
related to 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 to compile and
publish Analytical Profiles of Drug Substances in a series of volumes of
which this is the tenth.
The concept of analytical profiles is taking hold not only for compendia1
drugs but, increasingly, in the industrial research laboratories. Analytical
profiles are being prepared and periodically updated to provide
physiochemical and analytical information of 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.
The cooperative spirit of our contributors has made this venture possible.
It is gratifying to note that increasingly profiles are being written not only in
industrial laboratories but also in academic institutions worldwide.
All those who have found the profiles useful are requested to contribute a
monograph of their own. The editors stand ready to receive such
contributions.
The goal to cover all drug substances with comprehensive monographs is
still a distant one. It is up to our perseverance to make it a reality.

Klaus Florey

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