Validation of a Liquid Chromatographic Method for Quantitation of Organic Compounds Leached from a Plastic Container into a Pharmaceutical Formulation

Dennis Jenke; Mary Jo Garber; David Zietlow

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Validation of a Liquid Chromatographic Method for Quantitation of Organic Compounds Leached from a Plastic Container into a Pharmaceutical Formulation

机译：验证从塑料容器浸入药物制剂中的有机化合物的液相色谱方法的有效性

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摘要

A chromatographic method for the quantitation of organic compounds leached from a plastic solution container and its associated secondary packaging is described and its validation is enumerated.

机译：描述了一种定量分析从塑料溶液容器及其相关的二级包装中浸出的有机化合物的色谱方法，并列举了其有效性。

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《Journal of liquid chromatography and related technologies 》 |2005年第2期| 共24页
作者
Dennis Jenke; Mary Jo Garber; David Zietlow;
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正文语种 eng
中图分类分析化学 ;
关键词
Plastic materials; Chromatographic method; Organic compounds; Medical applications; Container leachables;

机译：塑料;色谱法;有机化合物;医学应用;容器浸出液;

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专利

1. Validation of a Liquid Chromatographic Method for Quantitation of Organic Compounds Leached from a Plastic Container into a Pharmaceutical Formulation [J] . Dennis Jenke, Mary Jo Garber, David Zietlow Journal of liquid chromatography and related technologies . 2005 ,第2期

机译：验证从塑料容器浸入药物制剂中的有机化合物的液相色谱方法的有效性
2. Development and Validation of an Ion-Exclusion Chromatographic Method for the Quantitation of Organic Acids in Complex Pharmaceutical Products [J] . Dennis R. Jenke Journal of Chromatographic Science . 1998 ,第4期

机译：离子排斥色谱法用于复杂药品中有机酸定量的开发和验证
3. Development and Validation of Ultra Performance Liquid Chromatographic and Mass Spectrometric Method for Quantitation of Efavirenz from Active Pharmaceutical Ingredient [J] . Dileep M. Bhosale American Journal of PharmTech Research . 2014 ,第3期

机译：高效液相色谱和质谱法从活性药物成分中依非韦伦定量的开发与验证
4. DEVELOPMENT AND VALIDATION OF NEW CHROMATOGRAPHIC METHOD FOR ESTIMATION OF ONDANSETRON HCL IN BULK AND PHARMACEUTICAL FORMULATION [C] . Muitaba A, Kohli K, Baboota S Annual meeting exposition of the Controlled Release Society . 2010

机译：散装和药物配方中恩丹西酮盐酸盐的色谱分析新方法的开发与验证
5. Quantitation of pharmaceutical formulations and monitoring of pharmaceutical processes using process analytical technology techniques: Near infrared and Raman spectroscopy. [D] . Tumuluri, Venkat S. 2007

机译：使用过程分析技术技术对药物制剂进行定量和药物过程监控：近红外和拉曼光谱。
6. Validated High-Performance Liquid Chromatographic Method for the Estimation of Rosuvastatin Calcium in Bulk and Pharmaceutical Formulations [O] . Safwan Ashour, Soulafa Omar 2011

机译：经验证的高效液相色谱法估算散装和药物制剂中瑞舒伐他汀钙
7. Development and Validation of an Ion-Exclusion Chromatographic Method for the Quantitation of Organic Acids in Complex Pharmaceutical Products [O] . D. R. Jenke 1998

机译：复合药品中有机酸定量离子排阻色谱法的开发与验证

Validation of a Liquid Chromatographic Method for Quantitation of Organic Compounds Leached from a Plastic Container into a Pharmaceutical Formulation

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