Detection of unknown residual solvents of sodium hyaluronate product / 中国组织工程研究

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.