In the ICH Q3A Impurities in Drug Substances guidance, impurities are classified as organic, inorganic, and residual solvents. Within the inorganic impurities classification, the metals listed in Table 1 are important to control in food, dietary supplements, and drug articles. Many toxic metal impurities found in pharmaceutical articles have been controlled for years by application of the Heavy Metals test described in USP–NF General Chapter Heavy Metals <231>. However, the procedures and the methods contained in <231> lack the sensitivity, specificity, and recovery to monitor properly the levels of these metals. A number of additional chapters for the control of specific metals and other inorganic impurities are contained in USP–NF. This Stimuli article proposes a new USP General Chapter for the control of inorganic impurities in drug and dietary supplement articles intended for use in humans. ICH Q3A原料药杂质成分一文中将杂质成分划分为有机、无机和残留溶剂三类。而在无机杂质分类中，附表1所列各金属杂质则是食品、食品添加剂和药品中的重要监控对象。对药品中的多种有毒金属杂质一直是按照USP–NF重金属附录〈231〉中规定的重金属检测方法进行检测。但是〈231〉中所述方法对于此类金属杂质含量水平的监测来说缺乏相应的灵敏性、专属性和重现性。USP-NF在其他几个附录章节中对特定金属杂质和其他无机不纯物的检测亦做有相应规定。
没有人关心这个吗？ 药典论坛第36卷第1期：A General Notices statement indicating <232> apply to all monographs, even if not specified 凡例中将新增声明：通则<232>适用于所有各论，即使不做特别说明，也就是说如同有机残留溶剂一样，所有产品都必须检测这一项。涉及到的仪器有电感耦合等离子体原子发射光谱仪，电感耦合等离子体质谱仪，一般的实验是没有这种仪器的，因此可能会增加企业的成本，我觉得这一点影响还是很大的。
General Chapter Heavy Metals <231> are inadequate to provide the basis for control of the elements in <232> at their proposed limits. The Chapter also provides limits of metal catalysts that can be added in the production of a drug substance or excipient. This Chapter also describes three separate options for determination of compliance to the limits. These options are similar to those presented in General Chapter Residual Solvents <467>. A revision is proposed to the General Notices to indicate that General Chapters h232i and h233i will apply to all oral and parenteral articles in USP–NF. This revision is sim- ilar in content to that describing the residual solvents re- quirements. They recommend that the committee consider an official date that coincides with the official date of the EMEA Metal Catalyst guide- line (Sept. 2013). 出口美国及欧盟的得相当注意了，需提前准备！
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