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_43
Snippet: The accuracy, precision, robustness, and linearity of the method are summarised in Table 2 . Recovery experiments gave 97.9e100.7% recovery for 1,4-dioxane (Table S1 ). The repeatability of the method was expressed as % RSD of five continuous standards, and the %RSD of peak area was 0.6%. %RSD of retention time and peak area that described intraday precision were 0.01% and 0.58%, respectively (n Z 6). Interday precision was calculated to describe.....
Document: The accuracy, precision, robustness, and linearity of the method are summarised in Table 2 . Recovery experiments gave 97.9e100.7% recovery for 1,4-dioxane (Table S1 ). The repeatability of the method was expressed as % RSD of five continuous standards, and the %RSD of peak area was 0.6%. %RSD of retention time and peak area that described intraday precision were 0.01% and 0.58%, respectively (n Z 6). Interday precision was calculated to describe intermediate precision of retention time and peak area, which were 0.02% and 0.62% (n Z 12), respectively (Table S2 ). The linear range for 1,4-dioxane was determined as 1e40 ppm. The calibration curves were linear for all the standard components with correlation coefficient !0.9999. LOD and LQD for 1,4-dioxane were 1 ppb and 5 ppb, respectively. The results showed that the resolution, tailing factor, and the number of theoretical plates when the column was changed to DB-624 met the system suitability requirements. %RSD of six samples was 1.6% between Hp-5ms and DB-624 (Table S3 ), implying that the area of target peak had little changes. All of the results met the requirement of the guideline 9101 described in the Chinese Pharmacopoeia 2015 Edition [26] (Table 2) .
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