Detection of unknown residual solvents of sodium hyaluronate product
10.3969/j.issn.1673-8225.2009.38.009
- VernacularTitle:医用透明质酸钠凝胶未知残留物的检测
- Author:
Dawei LU
;
Tingfei XI
;
Xiaoming FENG
;
Xue SUN
- Publication Type:Journal Article
- From:
Chinese Journal of Tissue Engineering Research
2009;13(38):7447-7450
- CountryChina
- Language:Chinese
-
Abstract:
BACKGROUND: A mass of unknown remains are founded in sodium hyaluronate product when it was tested for quality control. OBJECTIVE: To qualify and quantify unknown residual solvents of sodium hyaluronate product and determine hazardsaccording to standard toxicological data. DESIGN, TIME AND SETTING: A quality and quantity study with combined gas chromatography mass spectrometry was performed at National Institute for the Control of Pharmaceutical and Biological Products from May to June 2007.MATERIALS: Experimental samples were spot-checked, and purified water was also used.METHODS: The samples were qualified and quantified using combined gas chromatography mass spectrometry.MAIN OUTCOME MEASURES: Methanol, xylene and ethyl benzene were qualified and quantified.RESULTS: Combined gas chromatography mass spectrometry demonstrated that residual solvents in the sodium hyaluronateproducts were methanol, xylene, and ethyl benzene. The quantization of methanol was 414.365 μg/mL, the quantization of o-xylene was 0.19 μg/mL, and the quantization of ethyl benzene was 0.22 μg/mL. CONCLUSION: Methanol, xylene, and ethyl benzene were firstly identified as residual solvents in sodium hyaluronate products. Besides, we discussed methods of qualifying and quantifying these three residual solvents.
