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Different levels of genotoxic impurities 1-methyl-4-nitroso piperazine (MNP) and 1-methyl-4-nitroso piperazine (CPNP) were detected in rifampicin and rifapentine capsules. In this study, the nitrite ions in rifampicin and rifapentine capsules were determined by solid phase extraction-ion chromatography to explore the relationship between the content of nitrite ions and the formation of above genotoxic impurities.
The method of solid phase extraction-ion chromatography used for nitrite determination was established and validated.
Nitrite ion was not detected in rifampicin and rifapentine capsules with different levels of MNP and CPNP.
It is speculated that the origin of MNP and CPNP in rifampin and rifapentine capsules was not from nitrite ion, but derived from oxidative degradation of API.
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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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