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The residual metal impurities in cisplatin,carboplatin and oxaliplatin were determined by ICP-AES.The samples were ignited and dissolved with HC1:HNO3 (3:1).The method is simple and accurate.By the determination of the metal residues in the samples,the calculated actual daily exposure and concentration of the metal Pd,Ir,Rh,Ru,Mo,Ni,Cr,V,Cu,Mn,Fe and Zn that were less than the permitted daily exposures (PDE)and the limited concentration permitted in the EMEA guideline on the specification limits for residues of metal catalysts or metal reagents[1].The metal residues can de adequately removed from the active pharmaceutical ingredients and the corresponding drugs.The trace metal residues will not affect human health and lead to the safety hazard by the intravenous injection.

参考文献

[1] Guideline on the Specification Limits for Residues of Metal Catalysts or Metal Reagents[M].London:European Medicines Agency,2008:1-34.
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[3] Guideline on the Limits of Genotoxic Impurities[M].London:European Medicines Agency/Committee for Medicinal Products for Human Use,2006:1-8.
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[7] 李光俐,徐光,何姣,王应进,安中庆.ICP-AES法测定抗癌药物奥沙利铂中微量银、钯、镉[J].贵金属,2009(03):34-36.
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