Recent Trends in Product Development and Regulatory Issues on Impurities in Active Pharmaceutical Ingredient (API) and Drug Products. Part 2: Safety Considerations of Impurities in Pharmaceutical Products and Surveying the Impurity Landscape
Journal Title: AAPS PharmSciTech - Year 2014, Vol 15, Issue 1
Abstract
There are inconsistent identification and qualification thresholds for impurities in drug substances and drug products, particularly for degradation impurities that may be common to both a drug substance and a corresponding product. The inconsistencies, expressed as total daily intake (TDI) of an impurity, are magnified at relatively low doses (see Table ​TableII). II ). For example, with a daily dose of 1 mg, the qualification thresholds are 1.5 and 10 μg for impurities in drug substances and drug products, respectively. Should the ICH Q3A and Q3B guidelines be revised to make these thresholds more consistent? Other questions such as differentiating impurity thresholds based on use of the drug (e.g., chronic vs. acute therapy) also remain.
Authors and Affiliations
Karen M. Alsante, Kim C. Huynh-Ba, Steven W. Baertschi, Robert A. Reed, Margaret S. Landis, Scott Furness, Bernard Olsen, Mark Mowery, Karen Russo, Robert Iser, Gregory A. Stephenson, Patrick Jansen
Keywords
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