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Total Nitrosamine Testing for Pharmaceuticals Introduced

机译:介绍药物的总亚硝胺测试

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摘要

As the European Medicines Agency (EMA) risk assessment deadline takes hold, Ellutia's total nitrosamines pre-screening solution offers the pharmaceutical industry a simple, accurate and reliable test. This delivers a clear pass/fail result for apparent total nitrosamine content (ATNC) in minutes, allowing samples to be immediately cleared for processing or sent for further testing. From April 2020, all marketing authorisation holders of medicines containing chemically synthesised active pharmaceutical ingredients (APIs) must conduct a risk assessment to evaluate the possibility of nitrosamines being present.
机译:由于欧洲药物局(EMA)风险评估截止日期占据,Ellutia的亚硝胺总预筛选解决方案提供了制药行业的简单,准确可靠的测试。 这可以在几分钟内为明显的总亚硝酸胺含量(ATNC)提供清晰/失败的结果,允许立即清除样品以进行处理或发送进一步测试。 从2020年4月开始,所有含有化学合成活性药物成分(API)的药物的营销授权持有者必须进行风险评估,以评估存在的亚硝胺的可能性。

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