應用《中國藥典》2015年版四部通則0861殘留溶劑測定法對藥品中的殘留溶劑進行測定.方法 以頭孢硫脒的殘留溶劑檢測為例,探討了在使用固定的殘留溶劑檢測方法不能有效測定樣品中的殘留溶劑時,如何應用《中國藥典》2015年版四部通則0861的方法測定樣品中的殘留溶劑.結果 應用《中國藥典》2015年版通則0861殘留溶劑測定法,對不同生產廠家的頭孢硫脒中的殘留溶劑進行了全面準確的測定.結論 在固定的殘留溶劑測定方法不能準確測定藥品中的殘留溶劑時,應用《中國藥典》2015年版通則0861中的雙柱定性方法可以快速、準確地鑒別出藥品中未知的殘留溶劑,針對待測樣品建立準確的殘留溶劑測定方法.
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編號:20231124006
型號:GDX-101填充柱
規(guī)格:2m*3MM,60-80目
使用溫度:250°C
應用: yao典2025年版四部0521,0861,溶劑殘留測定
適用于:島津,安捷倫,賽默飛,瓦里安,布魯克,PE等
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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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