Full
Outline
To identify the potential risk of N-nitrosamines in azithromycin and to establish corresponding method for confirmatory testing, providing reference for risk assessment by manufacturers.
In conformity with the relevant industry guidance of FDA and EMA, risk identification and control limits for potential N-nitrosamines in azithromycin was conducted based on the structure and synthetic route, as well as degradation test. A liquid chromatography-mass spectrometry method was subsequently established and applied to the confirmatory testing of N-nitrosodimethylamine in azithromycin injection of 61 batches from 15 different manufacturers.
N-nitrosodimethylamine was probably introduced from starting material or generated as the degradation product of azithromycin. In all cases, N-nitrosodimethylamine were found below the limit of quantitation.
The risk of potential N-nitrosamines in azithromycin injection was acceptable. This method proved sensitive, selective, accurate and suitable to the confirmatory testing and quality control of N-nitrosodimethylamine in azithromycin injection. The article also provided an example to the risk assessment and confirmatory testing of potential N-nitrosamines in chemically synthesized APIs and drug products.
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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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