费休氏法水分测定的兽药检测实验室能力验证

Laboratory proficiency testing of veterinary drug inspection for moisture determination by Karl Fischer method

关键词:  费休氏法水分测定  能力验证  Z比分数

Key words:  moisture determination  proficiency testing  Z-score

摘要:

为进一步加强兽药检测机构能力建设,提升兽药检验水平,确保兽药检验质量,组织了兽药检测实验室等相关机构开展费休氏法水分测定能力验证。依据《中国兽药典》2015年版一部附录0832第一法容量滴定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验证。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,以理论计算值作为指定值。报告检测结果的50家兽药检测实验室中,39家的结果为满意,4家结果有问题,7家结果为不满意。通过研究,制备了均匀性和稳定性均符合能力验证要求的测试样品,并采用适当的统计方法评估了兽药检测实验室的水分检测能力。

Abstract:

In order to further strengthen the capacity building of veterinary drug testing institutions, improve veterinary drug testing level, and ensure veterinary drug testing quality, veterinary drug testing and other relevant institutions were organized to carry out the proficiency testing of water determination ability of Karl Fischer method. This proficiency testing was carried out according to the volumetric titration method of appendix 0832 of the Chinese Veterinary Pharmacopoeia (2015 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 theoretical calculated values were used as the specified values. Of the 50 veterinary drug testing laboratories that reported the results, 39 laboratories were satisfactory, 4 laboratories were problematic and 7 laboratories were unsatisfactory. Through the research, homogeneous and stable test samples were prepared, and the water detection ability of veterinary drug testing system laboratory was evaluated by appropriate statistical methods.