[HTML][HTML] 化学药品杂质谱控制的现状与展望

胡昌勤, 张夏 - 药学学报, 2019 - html.rhhz.net
对药品杂质谱的控制是保证药品安全有效的重要措施, 也是提升国产药品质量的关键环节.
自2010 年提出实施杂质谱控制的基本策略以来, 经近十年持续的努力, 国内已经形成了一个比较 …

Materials in manufacturing and packaging systems as sources of elemental impurities in packaged drug products: An updated literature review

D Jenke - PDA Journal of Pharmaceutical Science and …, 2020 - journal.pda.org
Elemental impurities in drug products arise from different sources and via a number of
different means, including leaching of elemental entities (including the elements themselves …

Research progress on the impurities identification and determination in pharmaceuticals

Y Chen, Z Zhang, X Gao, X Guo - Authorea Preprints, 2023 - essopenarchive.org
Rationale: Impurities refer to any substances that affect the purity of pharmaceuticals.
Controlling impurities has always been a significant concern during drug development …