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Center for Evidence-Based and Translational Medicine of Wuhan University
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Impurities
电感耦合等离子体-质谱法测定药用辅料山梨酸钾中元素杂质残留量
PANG Sai
JIANG Kun
WANG Ping
DOI:10.12173/j.issn.1008-049X.202402056
Potassium sorbate
Medicinal excipient
Inductively coupled plasma-mass spectrometry
Element
impurities
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Q3D
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注射用兰索拉唑杂质检测优化与细胞毒性评估
ZHANG Hao
ZHENG Hang
QIAO Lu
CHEN Ji
DOI:10.12173/j.issn.2097-4922.202509044
Lansoprazole
Impurities
detection
High-performance liquid chromatography
Cytotoxicity
Quality control
Method validation
Chinese Pharmacopoeia
Relative proliferation rates
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UPLC法同时测定布洛芬及其制剂中的10种杂质
YUN Xiaofei
ZHANG Yanxia
QIAN Yujuan
HAN Feng
XIAO Honghua
YAN Zeman
WANG Meng
DOI:10.12173/j.issn.2097-4922.202512006
Ibuprofen
Ultra-performance liquid chromatography
Impurities
Toxicity
Quality control
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基于小儿消积止咳口服液包材变更的元素杂质安全性考察
JIANG Mingyue
WANG Yonggang
CAO Jixiang
ZHANG Wei
FAN Jianwei
SU Ruiqiang
DOI:10.12173/j.issn.2097-4922.202605016
Xiao'er Xiaoji Zhike oral liquid
Content determination
Medicinal composite film
Elemental
impurities
Packaging material replacement
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亚硝胺类原料药相关杂质的控制策略分析
LI Hao
QI Qiancheng
ZHANG Shuai
SUN Caixia
DOI:10.12173/j.issn.2097-4922.202602037
Nitrosamine drug substance-related
impurities
Control strategies
Risk assessment
Limit determination
Analytical methods
Elimination strategies
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