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Strategy to Assess and Control Nitrosamine Formation

有机合成与工艺文献分享 2024-12-03 07:11
文章摘要
本文探讨了在药物活性成分（API）中形成亚硝胺杂质的策略。文章提出了一个新的亚硝胺杂质分类：与杂质相关的亚硝胺（IRNs），并介绍了在存储过程中，西格列汀盐酸盐一水合物中NTTP形成的案例研究。研究发现，不同等级的API在存储过程中NTTP含量均有所增加，且形成速率受温度影响。压力测试表明，空气暴露、适宜的pH值和足够的三唑吡嗪杂质是NTTP形成的关键触发因素。尽管API中的亚硝酸盐含量很低，但仍可能对亚硝化过程有贡献。基于这些发现，文章提出了通过改变包装材料来减少NTTP形成的缓解策略，并设计了一种通用的方法来识别、评估和减轻存储过程中IRN的形成。
Strategy to Assess and Control Nitrosamine Formation
查看文献： Strategy to Assess and Control Nitrosamine Formation in API during Storage: A Sitagliptin Case Study
查看期刊：Organic Process Research & Development
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