应用《中国药典》2015年版四部通则0861残留溶剂测定法对药品中的残留溶剂进行测定.方法 以头孢硫脒的残留溶剂检测为例,探讨了在使用固定的残留溶剂检测方法不能有效测定样品中的残留溶剂时,如何应用《中国药典》2015年版四部通则0861的方法测定样品中的残留溶剂.结果 应用《中国药典》2015年版通则0861残留溶剂测定法,对不同生产厂家的头孢硫脒中的残留溶剂进行了全面准确的测定.结论 在固定的残留溶剂测定方法不能准确测定药品中的残留溶剂时,应用《中国药典》2015年版通则0861中的双柱定性方法可以快速、准确地鉴别出药品中未知的残留溶剂,针对待测样品建立准确的残留溶剂测定方法.
编号:20231124006
型号:GDX-101填充柱
规格:2m*3MM,60-80目
使用温度:250°C
应用: yao典2025年版四部0521,0861,溶剂残留测定
适用于:岛津,安捷伦,赛默飞,瓦里安,布鲁克,PE等
The determination of residual solvents in drugs was carried out using the 0861 residual solvent detection method in the 2015 edition of the Chinese Pharmacopoeia. Taking the detection of residual solvents in ceftriaxone as an example, this study explored the effectiveness of using fixed residual solvent detection methods when residual solvents in samples cannot be effectively determined, How to apply the method specified in the 2015 edition of the Chinese Pharmacopoeia to determine residual solvents in samples? Results: The residual solvent determination method specified in the 2015 edition of the Chinese Pharmacopoeia was applied to comprehensively and accurately determine residual solvents in cephalosporin from different manufacturers. Conclusion: When fixed residual solvent determination methods cannot accurately determine residual solvents in drugs, The dual column qualitative method in the 2015 edition of the Chinese Pharmacopoeia General Rule 0861 can quickly and accurately identify unknown residual solvents in drugs, and establish an accurate residual solvent determination method for the test sample
Number: 20231124006
Model: GDX-101 filled column
Specification: 2m * 3MM, 60-80 mesh
Operating temperature: 250 ° C
Application: Yao Dian 2025 Edition Part 4 05210861, Solvent Residue Determination
Applicable to: Shimadzu, Agilent, Thermo Fisher, Varian, Brooke, PE, etc
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