September 27, 2010 Cover, Vol. 88, Issue 39
Guidelines On Genotoxicity
Regulators' conservative limits have drugmakers clambering to avoid or reduce DNA-reactive impurities. (pp. 16-29)
COVER: Laboratory assays such as the Ames test can identify pharmaceutical impurities. iStock
Genotoxic Impurities pp. 16-26
Faced with new guidelines that many find constraining, pharmaceutical manufacturers are seeking ways to avoid or reduce harmful contaminants in drugs.
Detecting Low-Level Impurities pp. 27-29
Controlling genotoxic impurities means finding the analytical method best suited to the task.
Copyright © 2010 American Chemical Society
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