USP36 232 ELEMENTAL IMPURITIES 元素杂质--限度 (中英文).doc

232ELEMENTAL IMPURITIES—LIMITS 元素杂质—限度 INTRODUCTION 介绍 This general chapter specifies limits for the amounts of elemental impurities in drug products. Elemental impurities include catalysts and environmental contaminants that may be present in drug substances, excipients, or drug products. These impurities may occur naturally, be added intentionally, or be introduced inadvertently (e.g., by interactions with processing equipment). When elemental impurities are known to be present, have been added, or have the potential for introduction, assurance of compliance to the specified levels is required. A risk-based control strategy may be appropriate when analysts determine how to assure compliance with this standard. Due to the ubiquitous nature of As, Cd, Pb, and Hg, they (at the minimum) must be considered in the risk-based control strategy. Regardless of the approach used, compliance with the limits specified is required for all drug products. 本章说明了药品中元素杂质的数量限度。元素杂质包括可能会存在于原料药、辅料或制剂中的催化剂和环境污染物。这些杂质可能会自然生成的、有意加入的或不可逆引入（例如与生产设备的相互反应）的。如果已知元素杂质存在、被加入或有引入的可能性，则必须保证其符合指定限度。分析人员在决定如何保证符合本标准时，可以适当采用基于风险的控制策略。由于砷、镉、铅和汞在自然中普遍存在，在采用基于风险的控制策略时必须包括对这四种元素的考虑。不论采用何种方式，所有药品均需符合指定的限度。 The limits presented in this chapter do not apply to excipients and drug substances, except where specified in this chapter or in the individual monographs. However, elemental impurity levels present in drug substances and excipients must be known and reported. 在本章中给出的限度不适用于辅料和原料药，除非在本章或各论中有说明。但是，原料药和辅料中的元素杂质水平必须知道并报告。 The limits indicated in this chapter are not required for articles intended only for veterinary use and conventional vaccines. Dietary supplements and their ingredients are addressed in Elemental Contaminants in Dietary Supplements2232 .1 本章中指出的限度不适用于仅供兽用品种和传统疫苗。膳食补充剂及其成分在《膳食补充剂元素污染物2232》中已有说明。 SPECIATION 杂质形态 The determination of the oxidation state, organic complex, or combination is termed speciation. Each of the elemental impurities has the potential to be present in differing oxidati