| 顶空气相色谱法测定原料药中正丁醇和乙酸乙酯含量的方法验证 |
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| 引用本文： | 丁恩峰,高海燕,韩志伟. 顶空气相色谱法测定原料药中正丁醇和乙酸乙酯含量的方法验证[J]. 医药工程设计, 2006, 27(4): 30-32 |
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| 作者姓名： | 丁恩峰 高海燕 韩志伟 |
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| 作者单位： | 河北新世纪药业有限公司,河北,石家庄,050031 |
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| 摘 要： | 验证是实施GMP的基础。在验证工作中，分析方法的验证是其他验证的基础，也是验证工作中的难点。笔者一直从事质量标准的制订和分析方法的优化。通过自己对工作经验的总结，希望为其他分析工作者提供借鉴。
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| 关 键 词： | 验证 分析方法 含量测定 准确度 精密度 专属性 检测限 定量限 线性 范围 耐用性 |
| 修稿时间： | 2006-02-14 |
Verification of Gas Color Spectrum Approach for Measuring N-Batyl Alcohol and Ethyl Acetate in Raw Medicine |
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| DING Enfeng,GAO Haiyan,HAN Zhiwei. Verification of Gas Color Spectrum Approach for Measuring N-Batyl Alcohol and Ethyl Acetate in Raw Medicine[J]. Pharmaceutical Engineering Design, 2006, 27(4): 30-32 |
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| Authors: | DING Enfeng GAO Haiyan HAN Zhiwei |
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| Abstract: | Verification is the basis of execution of GMP. In verification, the verification of the analysis methods is the basis of other verification, and also is the most difficult point in verification. The author has been engaging in the formulating of quality standards and the optimization of the analysis methods for long time. Through summing up the practical experience, the references were hoped to provide for other analytical workers. |
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| Keywords: | Vverification Analysis method Measurement of containment Veracity precision Exclusive property Inspection limit Quantitative limit Linearity Scope Durability |
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