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EDQM推进缬沙坦所含基因毒性杂质调查

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发表于 2018-9-19 14:39:08 | 显示全部楼层 |阅读模式

The EDQM is continuing the investigations and actions which started in July 2018 to address the issue related to the detection of N-nitrosodimethylamine (NDMA) in a source of active substance valsartan.

Following the complete review of the manufacturing information submitted in all Certificate of suitability (CEP) applications for valsartan and other structurally related active substances (e.g. losartan, olmesartan medoxomil, candesartan cilexetil), the EDQM has firstly contacted those CEP holders whose substances may present a contamination risk and has requested that they investigate and address the possible presence of NDMA.


近日,EDQM基于调查分析,要求将某供应商缬沙坦包含的NDMA杂质的调查,扩展到工艺近似的产品,如氯沙坦、奥美沙坦酯、坎地沙坦酯等,并已向持有这些产品CEP证书的企业函询。

个人认为,即使没有CEP证书,上述产品生产企业,亦应适时启动调查,以防范风险,自证清白。


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