| 喻亮宇,黄海萍.顶空气相色谱法同时测定药品包装材料中14种残留溶剂量[J].中国药品标准,2018,19(3):191-195 |
| 顶空气相色谱法同时测定药品包装材料中14种残留溶剂量 |
| Simultaneous Determination of 14 kinds of Residual Solvents of Pharmaceutical Packaging Materials by Headspace Gas Chromatography |
| 投稿时间：2018-03-01 修订日期：2018-06-11 |
| DOI： |
| 中文关键词: 药品包装用复合膜材料 顶空气相色谱法 残留溶剂量 |
| 英文关键词: Laminated film materials for pharmaceutical packaging Headspace gas chromatography Determination of residual solvent |
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| 中文摘要: |
| 目的： 建立药品包装用复合膜材料中残留溶剂量的测定方法。方法： 采用顶空气相色谱法对药品包装用复合膜材料中甲醇、乙醇、异丙醇等14种残留溶剂进行含量测定。结果： 14种残留溶剂在同一色谱条件下能完全分离，线性关系良好，r均大于0.995，平均回收率范围在75.34%～102.31%，检出限范围在0.001～0.004mg/m2，3批样品测定结果为0.09～0.24mg/m2。 结论：本法经方法学验证能有效地控制药品包装用复合膜材料中残留溶剂量。 |
| 英文摘要: |
| Objective: Establish the method for determination of residual solvent of laminated film materials for pharmaceutical packaging. Method: Determinate 14 kinds of residual solvents of laminated film materials for pharmaceutical packaging such as methanol, ethanol and isopropanol by headspace gas chromatography. Result:14 kinds of residual solvents can be completely separated in the same chromatographic condition,the linear ranges are good, r≥0.995,the average recoveries are in the range of 75.34%-102.31%, the detection limits are in the range of 0.001-0.004mg/m2,the results of 3 batches of samples are 0.09-0.24mg/m2. Conclusion: The improved method by Methodologies validated can be used to control the residual solvent of laminated film materials for pharmaceutical packaging efficiently. |
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