| 魏传波,房杰,杜瑞.非无菌原料药中可见异物的鉴别和来源分析[J].中国药事,2018,32(5):599-602 |
| 非无菌原料药中可见异物的鉴别和来源分析 |
| Identification and Source Analysis of Visible Foreign Particles in Non-sterile APIs |
| 投稿时间：2017-09-30 |
| DOI：10.16153/j.1002-7777.2018.05.005 |
| 中文关键词: 非无菌原料药 可见异物 来源分析 可接受标准 生产管理 纠正措施 预防措施 |
| 英文关键词: non-sterile APIs visible foreign particles source analysis acceptable criteria production management corrective actions preventive actions |
| 基金项目: |
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| 摘要点击次数: 1864 |
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| 中文摘要: |
| 目的：判定非无菌原料药中可见异物的来源，采取针对性的纠正预防措施，将其控制到合理的限度以下。方法：以生产过程中与物料直接接触的器具和部件为参照物，借助电镜扫描、元素分析和IR分析等手段进行比对分析，确认可见异物的来源。结果与结论：可见异物是工艺中产生和不可避免的，但能够通过理论计算确定100 g样品中粒径在1 mm以下的可见异物应小于9个。 |
| 英文摘要: |
| Objective:To determine the source of visible foreign particles in non-sterile active pharmaceutical ingredients (APIs) and to take appropriate corrective and preventive actions to control them below a reasonable limit. Methods:Appliances and components in direct contact with materials were chosen as reference substances and the source of visible foreign particles was confrmed by means of electron microscope scanning, elemental analysis and IR analysis and so on. Results and Conclusion:The visible foreign particles were generated during the process and were unavoidable. It can be determined by theoretical calculation that the visible foreign bodies with diameter less than 1 mm in 100 g samples should be controlled within 9. |
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