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A new standard reference film for oxygen gas transmission measurements
Lan-Gui Xie1, Xia Zhao1, Si-Hong Dou1
1The Institute for Packaging Materials and Pharmaceutical Excipients Control, National Institutes for food and drug Control, 2 Tiantan Xi Li, Beijing 100050, People's Republic of China.
Abstract:
A novel reference film was characterized to improve the oxygen gas transmission measurement accuracy of plastic materials for pharmaceutical packaging. The material processing, homogeneity, stability, jointly determined value and uncertainty evaluation were discussed. The film is the first reference film characterized by multiple laboratories using both manometric and coulometric methods. The oxygen transmission rate of the reference film was 20.53 with the expanded uncertainty of 1.36. The newly characterized reference film can be used in the calibration and self-calibration of oxygen transmission measurement equipment and analytical method verification to improve the measurement accuracy and achieve traceable data.
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