INVESTIGATION OF INORGANIC EXTRACTABLES IN ELASTOMERIC MATERIALS FOR PHARMACEUTICAL APPLICATIONS

机译：药物应用中弹性材料中无机萃取物的研究

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The ICH Q3D "Guideline for Metal Impurities" and the announced USP Chapters 232 "Elemental Impurities -Limits" and 233 "Elemental Impurities - Procedures" which will replace chapter 231 "Heavy Metals" have been taken in consideration to examine typical rubber ingredients and rubber compounds by ICP-OES and ICP-MS. Also the influence of washing procedures on the reduction of extractables/leachables was tested.

机译：ich Q3D“金属杂质指南”和宣布的USP章节232“元素杂质 - 层”和233“元素杂质 - 程序”是考虑到替代第231章“重金属”的“元素杂质 - 程序”，以检查典型的橡胶成分和橡胶化合物通过ICP-OES和ICP-MS。还测试了洗涤程序对可提取物/鹿的减少的影响。

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《Inernational Conferenence on Extractables leachables europe》|2012年||共20页
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Heinz Kirchmeyer;
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中图分类药品;
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4. INVESTIGATION OF INORGANIC EXTRACTABLES IN ELASTOMERIC MATERIALS FOR PHARMACEUTICAL APPLICATIONS [C] . Heinz Kirchmeyer Inernational Conferenence on Extractables leachables europe . 2012

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5. Strain-induced crystallization in elastomeric polymer networks prepared in solution and sol-gel derived high-temperature organic-inorganic hybrid materials. [D] . Premachandra, Jagath Kumara. 1998

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6. Evaluation of Extractables in Processed and Unprocessed Polymer Materials Used for Pharmaceutical Applications [O] . Cheryl L. M. Stults, Jennifer M. Ansell, Arthur J. Shaw, 2015

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INVESTIGATION OF INORGANIC EXTRACTABLES IN ELASTOMERIC MATERIALS FOR PHARMACEUTICAL APPLICATIONS

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