| 顶空气相色谱法测定药品包装用复合膜、袋中溶剂残留量的不确定度评定 |
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| 引用本文： | 刘颖玲. 顶空气相色谱法测定药品包装用复合膜、袋中溶剂残留量的不确定度评定[J]. 现代仪器, 2013, 0(1): 76-78,85 |
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| 作者姓名： | 刘颖玲 |
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| 作者单位： | 云南省医疗器械检验所 |
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| 摘 要： | 按YBB00182002要求,采用顶空气相色谱法测定聚酯/低密度聚乙烯药品包装用复合膜、袋中溶剂残留量,依据JJFl059-1999、CNAS-GL06,对测量结果不确定度进行系统分析,找出影响的主要因素;对各不确定度分量进行评定和量化,计算合成标准不确定度和扩展不确定度,测定结果表示为:(0.12±0.01)mg/m2,k=2。
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| 关 键 词： | 气相色谱法 顶空进样 药品包装用复合膜、袋 溶剂残留量 不确定度 |
Evaluation of the measurement uncertainty of solvent residues in laminated films and pouches for pharmaceutical packaging by headspace gas chromatography |
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| Liu Yingling. Evaluation of the measurement uncertainty of solvent residues in laminated films and pouches for pharmaceutical packaging by headspace gas chromatography[J]. Modern Instruments, 2013, 0(1): 76-78,85 |
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| Authors: | Liu Yingling |
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| Affiliation: | Liu Yingling(Yunnan province Institute of Testing on Medical Appliance,Kunming 650034) |
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| Abstract: | According to YBB00182002,solvent residues in laminated films and pouches(PET/LDPE) for pharmaceutical packaging were determined by headspace gas chromatographic.According to JJFl059-1999,CNAS-GL06,the uncertainty of the measurement results was analyzed systematically.Every uncertainty component was evaluated and quantified.The result of the solvent residues in laminated films and pouches(PET/LDPE) for pharmaceutical packaging was expressed as :(0.12±0.01)mg/m2,k=2. |
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| Keywords: | Gas chromatography Headspace sampling Laminated films and pouches for pharmaceutical packaging Solvent residues Uncertainty |
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