Container Closure Integrity of Packaging System of Ceftazidime for Injection by Mass Extraction Method

GUO Yan-yan, ZHANG Wan-ying, QIU Yi-ting, REN Kun, WANG Xiao-lan, JIANG Yan, PU Xiao-cong

Packaging Engineering ›› 2023 ›› Issue (21) : 273-278.

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PDF(425 KB)
Packaging Engineering ›› 2023 ›› Issue (21) : 273-278. DOI: 10.19554/j.cnki.1001-3563.2023.21.034

Container Closure Integrity of Packaging System of Ceftazidime for Injection by Mass Extraction Method

  • GUO Yan-yan, ZHANG Wan-ying, QIU Yi-ting, REN Kun, WANG Xiao-lan, JIANG Yan, PU Xiao-cong
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Abstract

The work aims to establish a complete set of mass extraction method to study the container closure integrity of the packaging system of ceftazidime for injection (specification:15 mL; 1.0 g). The experimental parameters were optimized by testing the negative control samples, negative samples and positive samples to complete system suitability confirmation, detection limit confirmation and methodological confirmation of mass extraction method, and test the 6 batches of samples after storage at acceleration conditions (temperature:40 ℃±2 ℃ and relative humidity 75%±5%)for 0, 3 and 6 months. This method had a detection limit of 2 μm, which was sensitive and convenient and the container enclosure integrity of the product complied with the requirements. The mass extraction method can be used to study the container closure integrity of ceftazidime for injection in the headspace aseptic packaging system.

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GUO Yan-yan, ZHANG Wan-ying, QIU Yi-ting, REN Kun, WANG Xiao-lan, JIANG Yan, PU Xiao-cong. Container Closure Integrity of Packaging System of Ceftazidime for Injection by Mass Extraction Method[J]. Packaging Engineering. 2023(21): 273-278 https://doi.org/10.19554/j.cnki.1001-3563.2023.21.034
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