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.
作者信息
Alsante Karen M, Huynh-Ba Kim C, Baertschi Steven W, Reed Robert A, Landis Margaret S, Furness Scott, Olsen Bernard, Mowery Mark, Russo Karen, Iser Robert, Stephenson Gregory A, Jansen Patrick
机构信息
Pfizer Global Research and Development, Groton, Connecticut, USA.
出版信息
AAPS PharmSciTech. 2014 Feb;15(1):237-51. doi: 10.1208/s12249-013-0061-z. Epub 2013 Dec 21.
Abstract
摘要
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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.活性药物成分（API）和药品中杂质的产品开发与监管问题的近期趋势。第2部分：药品中杂质的安全性考量及杂质情况概述
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Implications of in-use photostability: proposed guidance for photostability testing and labeling to support the administration of photosensitive pharmaceutical products, part 1: drug products administered by injection.使用中的光稳定性影响：用于光稳定性测试和标签的建议指导，以支持光敏感药物产品的管理，第 1 部分：注射给药的药物产品。
J Pharm Sci. 2013 Nov;102(11):3888-99. doi: 10.1002/jps.23717. Epub 2013 Sep 5.
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Direct evidence of 2-cyano-2-propoxy radical activity during AIBN-based oxidative stress testing in acetonitrile-water solvent systems.在乙腈-水溶剂体系中 AIBN 基氧化应激测试过程中 2-氰基-2-丙氧基自由基活性的直接证据。
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