Author: Li, Ling; Long, Jing; Li, Long; Cao, Huijuan; Tang, Tingting; Xi, Xinghua; Qin, Ling; Lai, Yuxiao; Wang, Xinluan
Title: Quantitative determination of residual 1,4-dioxane in three-dimensional printed bone scaffold Document date: 2017_7_17
ID: qd2te842_48
Snippet: This method was validated with good accuracy and reproducibility and met the methodological requirements of the guideline 9101 described in the Chinese Pharmacopoeia 2015 edition. It is one of the indispensable files in medical device approval and registration. We used this established method to monitor the drying process of scaffolds to guarantee the residual 1,4-dioxane less than 380 ppm, according to Chinese Pharmacopoeia [26] . Our results sh.....
Document: This method was validated with good accuracy and reproducibility and met the methodological requirements of the guideline 9101 described in the Chinese Pharmacopoeia 2015 edition. It is one of the indispensable files in medical device approval and registration. We used this established method to monitor the drying process of scaffolds to guarantee the residual 1,4-dioxane less than 380 ppm, according to Chinese Pharmacopoeia [26] . Our results showed that 1,4-dioxane in the scaffolds lyophilised (À50 C, 50 Pa) for 2 days and then dried in vacuum (25 C, 50 Pa) for 7 days were below 380 ppm (Figure 4) . After examining the three-phase diagram of 1,4-dioxane, we found that the conditions of À50 C and 50 Pa for lyophilising are not efficient for removing 1,4-dioxane ( Figure S1 ) because in this environment 1,4-dioxane prefers solid rather than gas; therefore, we will further optimise the drying process by lowering the pressure or increasing the temperature to improve the freeze-dry efficiency. Our newly established quantitative method will also be used to verify this hypothesis.
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