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| 摘要: |
| 目的介绍药物中的残留溶剂。方法对ICH、欧洲药典、美国药典和中国药典有关残留溶剂等问题进行讨论。结果与结论对药物中的残留溶剂应引起重视并应规定其允许残留量。第3类溶剂的残留量可用干燥失重法测定，而大多数第1类和第2类溶剂的残留量则用顶空气相色谱法测定。 |
| 关键词: 残留溶剂 残留量 顶空气相色谱法 |
| DOI： |
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| The residual solvents in the drugs |
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CHEN Yun1，CHEN Guang-biao2，WAN Xian-li3
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| Abstract: |
| OBJECTIVETo introduce the residual solvents in drugs. METHODSThe related problems of the residual solvents presented in ICH, USP and ChP are discussed. RESULTS AND CONCLUSIONThe residual solvents remained in drugs must be paid attention and the permitted |
| Key words: Residual solvents residual limits static head-space GC |
