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Objective To establish a titration method for evaluating the uncertainty in the determination of thiomersal content in adsorbed diphtheria, tetanus, and acellular pertussis combined vaccine, and to identify the sources of significant uncertainty, improve laboratory detection ability. Methods The titration method was established according to the first method of the General Rules 3115 in the 2020 edition of the Pharmacopoeia of the People’s Republic of China, a mathematical model was established, and the sources of uncertainty in the detection process were analyzed to synthesize the standard uncertainty and extended uncertainty. Results In the determination of thiomersal content, all influencing factors have a certain effect. After type A evaluation and type B evaluation, the extended uncertainty${U}_{\mathrm{{rel}}}= {4.72}\%\left({K = 2}\right)$was obtained. Conclusion After evaluating the uncertainty introduced by each factor, it was found that the factors introducing significant uncertainty are mainly the titration process of the test sample. It is suggested that the titration process in low-temperature and other conditions be considered in subsequent method improvements.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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