| Composition and Safety Analysis of Lyophilized Rubber Stoppers |
| Received:September 20, 2022 Revised:September 27, 2022 |
| DOI：10.12136/j.issn.1000-890X.2024.06.0444 |
| Key Words: lyophilized rubber stopper；composition analysis；safety |
| Author Name | Affiliation | E-mail | | YUAN Yi | Hubei Institute for Drug Control | 49368474@qq.com | | ZHOU Shu | Hubei Institute for Drug Control | | | CHEN Xiaoli | Hubei Institute for Drug Control | | | LI Pengfei | Hubei Institute for Drug Control | | | HU Min* | Hubei Institute for Drug Control | |
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| Abstract: |
| The compositions and safeies of 70 batches of lyophilized rubber stoppers were analyzed.The results showed that，by combining multiple analytical techniques such as gas chromatography-mass spectrometry，inductively coupled plasma-optical emission spectroscopy，ion chromatography and thermal gravimetric analysis，the compositions of the lyophilized rubber stoppers could be analyzed，and the formula of the lyophilized rubber stoppers could be derived in reverse .Due to different compound formulas，there were significant differences in the qualities of the lyophilized rubber stoppers，and the lyophilized rubber stoppers contained varying levels of residual nitrosamines and polycyclic aromatic hydrcarbons.Compound formula，pre-treatment method，environmental humidity and storage time could all affect the moisture content of lyophilized rubber stopper. |
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