Full
Outline
To establish a risk assessment and control system for nitrosamine impurities in chemical drugs and apply it to the study of nitrosamine impurities in propranolol hydrochloride tablets.
Information was retrieved from various national drug regulatory agencies, PubMed, Elsevier and Wiley websites, and the formation mechanisms, toxicity assessment, and control measures of nitrosamine impurities were analyzed and summarized. Guidelines for risk assessment and control of nitrosamine impurities in pharmaceuticals were systematically reviewed.
A risk assessment and control system for nitrosamine impurities was constructed, covering four key aspects: risk assessment elements, determination of impurity limits, confirmatory testing, and process control factors. This system was applied to evaluate nitrosamine impurities in propranolol hydrochloride tablets. Using fishbone diagram analysis, risk factors for nitrosamine impurities were identified from aspects such as active ingredients, excipients, manufacturing processes, and storage conditions of the tablets. Samples from market surveillance and their raw materials were tested. Factors influencing the formation of nitrosamine impurities were preliminarily investigated through excipient compatibility studies, stress testing, and accelerated stability testing, and corresponding control measures were proposed.
The established risk assessment and control system for nitrosamine impurities in pharmaceuticals will aid in the development of strategies for managing these impurities. It also provides technical references for regulatory authorities and pharmaceutical companies to implement precise control of nitrosamine-related risks.
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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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