About: Quantitative determination of residual 1,4-dioxane in three-dimensional printed bone scaffold

Facets (new session)
Description
Metadata
Settings
- owl:sameAs
- Inference Rule:

About: Quantitative determination of residual 1,4-dioxane in three-dimensional printed bone scaffold Goto Sponge NotDistinct Permalink

An Entity of Type : schema:ScholarlyArticle, within Data Space : wasabi.inria.fr associated with source document(s)

Attributes	Values
type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	Quantitative determination of residual 1,4-dioxane in three-dimensional printed bone scaffold
Creator	Qin, Ling Li, Ling Li, Long Cao, Huijuan Lai, Yuxiao Long, Jing Tang, Tingting Wang, Xinluan Xi, Xinghua
Source	PMC
abstract	BACKGROUND/OBJECTIVE: A novel porous scaffold poly (lactide-co-glycolide) and tricalcium phosphate (PLGA/TCP) was developed by three-dimensional printing technology for bone defect repair. As a Class 2 solvent with less severe toxicity, content of residual 1,4-dioxane in this newly developed scaffold should be rigorously controlled when it is translated to clinical use. In this study, a headspace gas chromatography-mass spectrometric (HS-GC-MS) method and related testing protocol were developed for quantitative determination of 1,4-dioxane in the PLGA/TCP composite scaffolds. METHODS: Matrix effect analysis was used to optimise the pretreatment method of the scaffolds. Then, the procedure for testing 1,4-dioxane using HS-GC-MS was set up. The accuracy, precision, and robustness of this newly developed quantitative method were also validated before quantification of 1,4-dioxane in the scaffolds with different drying procedures. RESULTS: Dimethyl formamide (DMF) was the optimal solvent for dissolving scaffolds for GC-MS with proper sensitivity and without matrix effect. Then, the optimised procedure was determined as: the scaffolds were dissolved in DMF and kept at 90°C for 40 minutes, separated on a HP-5MS column, and detected by mass spectroscopy. Recovery experiments gave 97.9–100.7% recovery for 1,4-dioxane. The linear range for 1,4-dioxane was determined as 1–40 ppm with linear correlation coefficient ≥ 0.9999. Intraday and interday precision was determined as being within relative standard deviation of below 0.68%. The passable drying procedure was related to lyophilising (−50°C, 50 Pa) the scaffolds for 2 days and drying in vacuum (50 Pa) for 7 days. CONCLUSION: This is the first quantitative method established to test 1,4-dixoane in a novel scaffold. This method was validated with good accuracy and reproducibility, and met the methodological requirements of the Guideline 9101 documented in the Chinese Pharmacopoeia 2015 Edition. THE TRANSLATIONAL POTENTIAL OF THIS ARTICLE: This quantitative method for determination of residual 1,4-dioxane in the novel scaffolds is a key technical method during its translation into clinical use because this method is an important and indispensable file in the enterprise standard when the porous scaffold is registered as a Class III implanted medical device for bone defect repair, which is used to guarantee the safety of the scaffolds. It is also applied to optimise the drying process of scaffolds and to monitor the quality of scaffolds in the industrialisation process. Further, this method provides references for other solvents quantitative determination in porous scaffolds or materials.
has issue date	2017-07-17(xsd:dateTime)
bibo:doi	10.1016/j.jot.2017.06.004
bibo:pmid	29662792
has license	cc-by-nc-nd
sha1sum (hex)	f3644b5ed4c1c0fbf3e59e20f2ac8c5a88ddfd6c
schema:url	https://doi.org/10.1016/j.jot.2017.06.004
resource representing a document's title	Quantitative determination of residual 1,4-dioxane in three-dimensional printed bone scaffold
has PubMed Central identifier	PMC5894362
has PubMed identifier	29662792
schema:publication	J Orthop Translat
resource representing a document's body	covid:f3644b5ed4c1c0fbf3e59e20f2ac8c5a88ddfd6c#body_text
is schema:about of	named entity 'GAS CHROMATOGRAPHY' named entity 'EFFECT' named entity 'FORMAMIDE' named entity 'BACKGROUND' named entity 'TESTING' named entity 'DETECTED' named entity 'VALIDATED' named entity 'CONTROLLED' named entity 'QUANTIFICATION' named entity 'PRINTING' named entity 'USED' named entity 'QUANTITATIVE' named entity 'SUMMARY' named entity 'KEYWORDS' named entity 'PLGA' named entity 'SENSITIVITY' named entity 'SCAFFOLD' named entity 'STUDY' named entity 'COMPOSITE' named entity 'SEPARATED' named entity 'DISSOLVED' named entity 'PROPER' named entity 'DRYING' named entity 'PROCEDURE' named entity 'TECHNOLOGY' named entity 'Results' named entity '1,4-dioxane' named entity 'translated' named entity 'The' named entity 'TCP' named entity 'Class 2' named entity 'PRINTED' named entity 'EXPERIMENTS' named entity 'GAS CHROMATOGRAPHY MASS SPECTROMETRY' named entity 'RELATED' named entity 'USE' named entity 'DETERMINATION' covid:arg/f3644b5ed4c1c0fbf3e59e20f2ac8c5a88ddfd6c named entity '2C4' named entity 'DIOXANE' named entity 'MATRIX' named entity 'TOXICITY' named entity '2C4' named entity 'PROTOCOL' named entity 'A CLASS' named entity 'CLASS 2' named entity 'RESIDUAL' named entity 'THREE-DIMENSIONAL' named entity 'DIOXANE' named entity 'AUTHORS' named entity 'POLY' named entity 'ACCURACY' named entity 'RECOVERY' named entity 'PRETREATMENT' named entity 'BONE DEFECT' named entity 'ANALYSIS' named entity 'DMF' named entity 'PRECISION' named entity 'NOVEL' named entity 'PROCEDURES' named entity 'DIMETHYL' named entity 'CONTENT' named entity 'CLINICAL' named entity 'TRICALCIUM PHOSPHATE' named entity 'NEWLY' named entity 'QUANTITATIVE' named entity 'SCAFFOLD' named entity 'BONE' named entity 'REPAIR' named entity 'DIFFERENT' named entity 'DETERMINATION' named entity 'DISSOLVING' named entity 'RESIDUAL'

Faceted Search & Find service v1.13.91 as of Mar 24 2020

Alternative Linked Data Documents: Sponger | ODE Content Formats:

RDF

ODATA

Microdata

About

OpenLink Virtuoso version 07.20.3229 as of Jul 10 2020, on Linux (x86_64-pc-linux-gnu), Single-Server Edition (94 GB total memory)
Data on this page belongs to its respective rights holders.
Virtuoso Faceted Browser Copyright © 2009-2024 OpenLink Software