EDQM推出铅、铬、汞、砷标准品

EDQM roll out reference standard for elemental impurities: lead, cadmium, mercury and arsenic

EDQM推出元素杂质铅、铬、汞、砷参考标准品

REFERENCE STANDARD CHEMICAL REFERENCE STANDARD (CRS)   NEWS

01 FEBRUARY 2018

2018年2月1日   

STRASBOURG, FRANCE

法国，斯特拉斯堡

The European Directorate for the Quality of Medicines and Healthcare (EDQM) announces the availability of four new elemental impurity chemical reference standards (CRS) in its European Pharmacopoeia catalogue: lead solution CRS, cadmium solution CRS, mercury solution CRS and arsenic solution CRS. These elements occurring in nature are amongst the greatest potential sources of elemental con**ination in medicinal products and substances for pharmaceutical use; the new reference standards underpin the European Pharmacopoeia (Ph.Eur.) chapter describing the determination of elemental impurities (2.4.20).

EDQM宣布了欧洲药典目录中四个新的元素杂质化学参考标准品的可用性，分别是：铅溶液标准品、铬溶液标准品、汞溶液标准品和砷溶液标准品。这些出现在自然界中的元素是药品和药用物质的最重要的元素污染潜在来源；新的参考标准品巩固了欧洲药典2.4.20元素杂质鉴定章节。

Element contents featured in these reference standards – which were developed in partnership by EDQM, the Joint Research Centre (JRC) of the EU Commission, the National Metrology Institute of Germany, Physikalisch-Technische Bundesanstalt (PTB), and the German Federal Institute for Materials Research and Testing (BAM) - are traceable to the SI (International System of units of measurements) and enable metrologically sound determination of lead, cadmium, mercury and arsenic as elemental impurities in medicinal products and substances for pharmaceutical use.

这些由EDQM、欧盟委员会的JRC、德国计量研究所、PTB和德国联邦材料研究与测试研究所一起合作研发的参考标准品中的元素含量源于国际剂量单位SI，并且能够计量测定药品和药用物质中的铅、铬、汞、砷的含量。

With the introduction of these reference standards, the EDQM is providing a tool that can support pharmaceutical manufacturers in their implementation of relevant public health standards, such as the ICH Q3D on Elemental Impurities, the quality guideline for the control of impurities in medicinal products.

通过引入这些参考标准，EDQM为支持制药厂商实施相关的公共卫生标准提供了一种工具，如 ICH Q3D的元素杂质和药品杂质控制的质量指南。

附件：铅、铬、汞、砷溶液第一批的标签和原产地证明