《中国药典》四部通则澄清度检查法中可能存在问题的探讨

Discussion on the Issues in the General Method 0902(Clarity and Degree of Opalescence of Liquids)of the Chinese Pharmacopoeia

目的:探讨《中国药典》(ChP)四部通则澄清度检查法中存在无法将浊度单位准确复现的问题,并尝试解决建议。方法:在14家不同实验室中采用统一的标准化作业指导书,按ChP 2020年版四部0902澄清度检查法和0401紫外-可见光光度法进行实验。结果:虽然参照ChP四部通则澄清度检查法的配制规定,但不同实验室所配制浊度标准贮备液、原液和各级号浊度标准液的相应浊度数值间仍存在较大差异。结论:在无法保证浊度单位溯源性的前提下,不同浊度标准贮备液间将存在差异,即在550 nm波长处的吸光度限值对浊度标准原液的浓度(浊度)并不具备质控效力。

Objective:The solutions were proposed to solve the issues,turbidity units cannot be reproduced accurately,existing in the general method 0902(Clarity and Degree of Opalescence of Liquids)of the ChP.Methods:The study was carried out in 14 labs with the unified SOP drawn up according with the general method 0902 and 0401 of the ChP 2020.Results:The primary opalescent suspension,standard of opalescence and reference suspensions used in each collaborative lab were strictly prepared in accordance with the requirements in the general method 0902 of the ChP.However,the corresponding opalescent values of the primary opalescent suspension,standard of opalescence and reference suspensions were significantly different among different collaborative labs.Conclusion:If the traceability for turbidity units cannot be guaranteed,the compositions of the primary opalescent suspension will be variable,that is,the concentration of the standard of opalescence will not be effectively controlled by the specified absorbance range determined at 550 nm.