USP-232中英对照-SP-38-NF-33.docxVIP

Second Supplement to USP 38-NF 33 Chemical Tests / 232 Elemental Impurities—Limits) 注：背景字体表示最新变化，232执行日期2018.01.01 Page 232ELEMENTAL IMPURITIES—LIMITS INTRODUCTION 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 and the container closure system). When elemental impurit