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




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