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Items
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Specification
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Description
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White to off-white crystalline powder
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Identification(HPLC)
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HPLC
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Identification D/USP<191>
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Positive test for sodium
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Assay/HPLC;USP <621>
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95.0%-105.0% on the anhydrous basis
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Limit of Beta Cyclodextrin(Betadex）IC;USP<621>;USP<1065>
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NMT0.1%
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Limit of 1,4-Butane Sultone/GC;USP<621>
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NMT0.5ppm
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Limit of Sodium chloride/IC;USP<621>;USP<1065>
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NMT0.2%
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Limit of 4-Hydroxybutane-1-sulfonic acid /IC;USP<621>;USP<1065>
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NMT0.09%
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Limit of Bis(4-solufobuty)ehter disodium/IC;USP<621>;USP<1065>
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NMT0.05%
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Bacterial Endotoxins Test /USP <85>
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≦10EU/g
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Microbial Enumeration /USP <61>
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TAMC≦100cfu/g TYMC ≦50cfu/g
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Tests for Specified Microorganisms /USP <62>
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Absence of Escherichia Coli/1g
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Clarity of Solution(30%,w/v)/Visual;see details in the USP Monograph
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The solution id clear,and essentially free from particles of foreign matter
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Average Degree of substitution[DS]/CE;USP <1053>
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6.2-6.9
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