OBJECTIVE To explore the extraction conditions for elemental impurities in metal containers used for drug packaging. METHODS Different extraction conditions were set, and the metal containers used for packaging 6 types of drugs were extracted separately. The content of the extracted elements was determined using inductively coupled plasma mass spectrometry. RESULTS When 4% acetic acid is used as the extraction medium, more impurities of elements are released from various containers. When using water as the extraction medium, the amount of As, Cd, Pb, V, Co, Ni, Cr, and Cu elements dissolved from various containers is basically the same when extracted at (121±2) ℃, held for 30 min or (70±2) ℃, and held for 24 h. For Mg, Al, Mn, Fe, and Zn elements, the extraction amount obtained by organic inner coating containers under two extraction conditions is basically the same. Containers with anodized and plasma sprayed inner walls, as well as bare metal containers, can leach more elements except for Mg at (121±2) ℃ for 30 min of insulation. CONCLUSION When determining elemental impurities in metal containers for drug packaging, 4% acetic acid can be selected as the extraction medium with stricter control. By water extraction at (70±2) ℃ and insulation for 24 h, it can meet the determination requirements of Class 1, Class 2A, and Class 3 elements in ICH-Q3D.
| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |