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药品审评过程中残留溶剂检查常见问题分析

Problem analysis of residual solvents control in drug evaluation

  • 摘要: 在药品审评工作中,残留溶剂检查经常出现以下问题:包括如何确定需进行残留量检查的溶剂、制剂的残留溶剂检查、顶空进样法的试验条件以及质量标准的拟定等。本文从以上几方面进行分析和讨论,为药学研究工作者进行残留溶剂研究提供参考。

     

    Abstract: Some problems were often found in the residual solvents control in drug evaluation,including the determination of the organic solvents for residual solvents study,the conduction of the residual solvents control of finished products,the determination of the experimental condition of headspace gas chromatography,and the establishment of the specification.These aspects were analysed with actual cases in drug evaluation process to provide some references for the pharmaceutical researchers.

     

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