Analytical chemistryPharmaceutical PreparationsQuality ControlUncertainty
Application of Analytical Measurement Uncertainty and Considerations toward Pharmaceutical Material Quality Control Strategies.
Michael A Zompa, Dolee Merai, Paul Oram, David J Lavrich, J David Christopher, Jorge Quiroz, Nick Montefusco, Alice Newman, Liam Corcoran, Jinjian Zheng, Xiaohua Zhang
Published: 202610.1021/acs.analchem.5c06322
Abstract
Guidance documents ICH Q14 and USP <1220> discuss the uncertainty associated with measurements and its impact on decisions regarding pharmaceutical materials. Through case studies, we demonstrate an approach for setting acceptance limits for analytic…
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