Since early July 2018 Official Medicines Control Laboratories (OMCLs) of the General European OMCL Network (GEON) have been involved in investigations and actions to address the issues related to the detection of N-nitrosodimethylamine (NDMA) in valsartan. The Network has meanwhile developed methods for the specific testing of nitrosamines in sartans on the basis different analytical principles.

自2018年7月初开始，OMCL参与了调查和行动解决缬沙坦中检出NDMA事件。该网络同时开发了基于不同的分析原理的缬沙坦中亚硝胺物特定方法。

Three of these methods - established by the Irish OMCL inthe Public Analyst’s Laboratory in Galway (PALG), by the French OMCL at the ANSM site in Montpellier and the German OMCL at the Chemisches undVeterinär-Untersuchungsamt (CVUA) Karlsruhe  on behalf of the Network - are now publicly available and can be accessed via the following links- PALG method, ANSM method and CVUA Karlsruhe method.

这些方法中的3个—由爱尔兰OMCL（PALG）、法国ANSM的OMCL和德国CVUA的OMCL代表网络开发—目前发布可通过以下链接下载：

• The PALG method is based on Headspace-GC-MS (single quad) and applicable to the determination of NDMA in Active Pharmaceutical Ingredients (API) and corresponding powdered tablets of the sartan group. （顶空GC-MS（单四极杆）方法，可用于检测沙坦类API及对应粉末片剂中NDMA）。

• The ANSM method uses HPLC-UV as general analytical principle for the determination of NDMA in valsartan (API and drug product). （HPLC-UV方法，用于检测缬沙坦API和制剂中NDMA）。

• The CVUA Karlsruhe method is based on APCI-UHPLC-MS/MS and applicable to the detection and quantitative determination of NDMA in valsartan drug products. （APCI-UHPLC-MS/MS方法，用于检出和定量缬沙坦制剂中NDMA）。

附件下载：OMCL发布3个沙坦中NDMA检测方法