| 摘要: |
| 为加强兽药检验检测机构能力建设,进一步提升检测技术水平,组织开展了全国省级兽药检验机构伊维菌素注射液含量测定的能力比对。依据《中国兽药典》2020年版一部附录0512高效液相色谱法以及中国合格评定国家认可委员会(CNAS)规定的程序进行本次能力比对。采用单因子方差分析对制备的测试样品进行均匀性检验,采用t检验对样品进行稳定性考察,采用Z比分数评价各参加实验室的测试结果,以稳健统计的平均值作为指定值。参加本次能力比对的34家兽药检测实验室中,32家结果为满意,满意率94.1%。 |
| 关键词: 伊维菌素注射液含量测定 能力比对 高效液相色谱法 Z比分数 |
| DOI： |
| 投稿时间：2021-10-04修订日期：2022-01-24 |
| 基金项目: |
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| Result analysis of laboratory capability comparison of veterinary drug inspection for content determination of Ivermectin Injection |
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| (China Institute of Veterinary Drug Control,Beijing,100081;China) |
| Abstract: |
| In order to strengthen the capacity-building of veterinary drug inspection and testing institutions and further improve the level of detection technology, veterinary drug testing and other relevant institutions were organized to carry out the capability comparison of content determination of Ivermectin Injection. This capability comparison was carried out according to appendix 0512 high performance liquid chromatography of the Chinese Veterinary Pharmacopoeia (2020 edition) and the procedure prescribed by China National Accreditation Service for Conformity Assessment (CNAS). The homogeneity of the samples was tested by one-way ANOVA, and the stability of the samples was examined by t-test which met the requirements. The Z-score was used to evaluate the test results of the participating laboratories. The average value of robust statistics was used as the specified values. Among the 34 veterinary drug testing laboratories participating in the capability comparison, 32 were satisfied, with a satisfaction rate of 94.1%. |
| Key words: content determination of Ivermectin Injection capability comparison high performance liquid chromatography Z-score |
