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 ninth.
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 to provide physicochemical 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 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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