Profiles of Drug Substances, Excipients, and Related Methodology, Volume 45, presents
comprehensive reviews of drug substances and additional materials, with critical review …

Profiles of Drug Substances, Excipients, and Related Methodology, Volume 47 covers all
aspects of drug development and formulation of drugs, meeting the information needs of the …

Although the official compendia define a drug substance as to identity, purity, strength, and
quality, they normally do not provide other physical or chemical data, nor do they list …

This book provides an overview of excipients, their functionalities in pharmaceutical dosage
forms, regulation, and selection for pharmaceutical products formulation. It includes …

Twenty years have passed since the publication of the first volume of Pharmaceutical
Analysis, which has since evolved into the Handbook of Pharmaceutical Analysis. The …

Pharmaceutical analysis is a broader term and there are many ways to define it. It is the
process or series of processes that can be used for the identification, determination …

Updated and revised throughout. Second Edition explores the chromatographic methods
used for the measurement of drugs, impurities, and excipients in pharmaceutical …

The current article surveys pharmaceutical analysis and related methodology that has
appeared in the literature since the last review in this series was published in Analytical …

Novel pharmaceutical excipients, and new derivatives of currently used excipients, are new
chemical entities and as such have to go through extensive pharmacokinetic and toxicologic …

Publisher Summary Analytical method validation is performed by regulated laboratory, and
deals with the testing of significant method characteristics to ensure that under routine use …