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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月初開始，OMCL參與了調(diào)查和行動(dòng)解決纈沙坦中檢出NDMA事件。該網(wǎng)絡(luò)同時(shí)開發(fā)了基于不同的分析原理的纈沙坦中亞硝胺物特定方法。

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.

這些方法中的3個(gè)—由愛爾蘭OMCL（PALG）、法國ANSM的OMCL和德國CVUA的OMCL代表網(wǎng)絡(luò)開發(fā)—目前發(fā)布可通過以下鏈接下載：

• 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. （頂空GC-MS（單四極桿）方法，可用于檢測(cè)沙坦類API及對(duì)應(yīng)粉末片劑中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，用于檢測(cè)纈沙坦API和制劑中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，用于檢出和定量纈沙坦制劑中NDMA）。

附件下載：OMCL發(fā)布3個(gè)沙坦中NDMA檢測(cè)方法