Analytical Profiles of Drug Substances and Excipients

This volume presents analytical profiles of drug substances and excipients. The definitions include details such as to identity, purity, strength, and quality of a drug substance as well as physical and chemical data, and methods of synthesis.

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Although the official compendia define a drug substance as to identify, purity, strength, and quality, 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. Such information is scattered throughout the scientific literature and the files of pharmaceutical laboratories. This text brings this information together into one source. The scope of the series has recently been expanded to include profiles of excipient materials.