国产注射用氨苄西林钠杂质谱与其生产工艺的相关性研究
Correlation study between production process and impurity profile of domestic ampicillin sodium for injection
分类号：
出版年·卷·期（页码）：2013,33 (3):0-0
DOI:
10.16155/j.0254-1793.2017.01.01
-----摘要：-------------------------------------------------------------------------------------------
目的:对不同生产工艺氨苄西林钠的杂质谱进行对比研究。 方法:采用氨苄西林钠有关物质测定方法,并进行破坏试验,对各杂质溯源。以190批次注射用氨苄西林钠有关物质检测结果为依据,考察不同工艺产品的杂质情况。 结果:溶媒结晶样品杂质个数最少且杂质量明显低于其他2种工艺样品,喷雾干燥样品杂质个数最多。 结论:原料药生产工艺与样品的杂质谱有一定相关性,是影响产品杂质的重要因素。
-----英文摘要：---------------------------------------------------------------------------------------
Objective: To compare and analyze the impurity profile of ampicillin sodium produced by different process. Methods: The impurities were deduced by using the related substances determination of ampicillin sodium and accelerated degradation tests.The impurity profile of ampicillin sodium produced by different process were investigated based on 190 batches of impurity testing data of ampicillin sodium for injection. Results: The amount of impurities of solvent crystallization process samples were much lower than freeze drying process samples and spray drying process samples.The spray drying samples had the most impurities. Conclusion: The productive technology of ampicillin sodium was closely correlated to their impurity profile.It was an important factor affecting the impurities.
-----参考文献：---------------------------------------------------------------------------------------
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