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Exploration and Determination of Leaching Conditions for Elemental Impurities in Metal Containers for Pharmaceutical Packaging
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Ying LI, Shusheng YUAN, Xia ZHAO*
Chinese Pharmaceutical Journal | 2024, 59(20) : 1962 - 1966
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Chinese Pharmaceutical Journal | 2024, 59(20): 1962-1966
Exploration and Determination of Leaching Conditions for Elemental Impurities in Metal Containers for Pharmaceutical Packaging
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Ying LI, Shusheng YUAN, Xia ZHAO*
Affiliations
  • National Institutes for Food and Drug Control, Beijing 100050, China
Published: 2024-10-22 doi: 10.11669/cpj.2024.20.011
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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.

metal containers  /  pharmaceutical packaging  /  elemental impurity  /  extraction medium  /  leaching condition  /  pharmaceutical packaging material
Ying LI, Shusheng YUAN, Xia ZHAO. Exploration and Determination of Leaching Conditions for Elemental Impurities in Metal Containers for Pharmaceutical Packaging[J]. Chinese Pharmaceutical Journal, 2024 , 59 (20) : 1962 -1966 . DOI: 10.11669/cpj.2024.20.011
Year 2024 volume 59 Issue 20
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doi: 10.11669/cpj.2024.20.011
  • Receive Date:2024-04-18
  • Online Date:2025-12-30
  • Published:2024-10-22
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  • Received:2024-04-18
Affiliations
    National Institutes for Food and Drug Control, Beijing 100050, China
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表12种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

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
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