药品中氮含量测定的能力验证

Proficiency-testing of Pharmaceutical Nitrogen Determination

依据国际纯粹与应用化学联合会(IUPAC)国际能力验证活动的规则以及中国合格评定国家认可委员会(CNAS)规定的程序,对参与药品中氮含量测定能力验证的实验室进行能力评价,并提供技术分析和建议。采用单因子方差分析对制备的能力验证样品(甘氨酸)进行均匀性检验,采用t检验考察样品稳定性,结果均符合要求。采用中位值和标准化四分位距法的稳健统计方法,用Z比分数评价各参加实验室的测试结果。报告检测结果的84家实验室中,76家的结果为"满意",4家的结果为"有问题",4家的结果为"不满意"。本次能力验证研究客观评价了实验室药品中氮含量的检测能力,提供了全面深入的技术分析,帮助实验室查找原因,采取措施,提高检测能力。

According to the protocol of International Union of Pure and Applied Chemistry （IUPAC） and procedure of China National Accreditation Service for Conformity Assessment （CNAS）, the pharmaceutical nitrogen determination capacity of the laboratories which participated in the proficiency-testing was evaluated, and some technical analyses and advices were provided. The one-way ANOVA was used to evaluate the homogeneity of the proficiency-testing samples （glycine）, whose stability was confirmed with t-test. All results conformed to the requirements. The median value and the normalized interquartile range （NIQR） of robust statistical method was adopted and Z-scores were used to evaluate the results from each laboratory. Among 84 laboratories which reported their results, 76 laboratories＇ results were ＂satisfactory＂, four were ＂questionable＂, and four were ＂unsatisfied＂. The in-depth comprehensive technical analysis could help the laboratories to find out the causes, take measures, and improve the detection capability.