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目的:按照《中国药典2010年版二部》[1]用RP-HPLC法对药品有关物质进行测量,对整个测量过程进行测量不确定度评定,并对不确定度结果进行了评定与合成。方法:采用测量不确定度评定方法。结果:用RP-HPLC法测量药物有关物质的扩展不确定度为±7.4%。结论:药品检验所在报告有关物质项目不合格时,应评定其测量不确定度,确保结论准确无误。
OBJECTIVE: According to the “Chinese Pharmacopoeia 2010 two” [1] using RP-HPLC method for the determination of drug-related substances, measuring the uncertainty of the measurement process, and the uncertainty of the results were evaluated and synthesized. Methods: Uncertainty evaluation method. Results: The extended uncertainty for the measurement of drug-related substances by RP-HPLC was ± 7.4%. Conclusion: When the drug test reports substandard material items, the measurement uncertainty should be assessed to ensure the conclusion is correct.