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ITEMS | SPECIFICATION | RESULTS | ||
Appearance | White to off-white, amorphous powder | Conform | ||
Solubility | Very soluble in water, sparingly soluble in methanol, practically insoluble in ethanol, in n-hexane, in 1-butanol, in acetonitrile, in 2-propanol and in ethyl acetate | Conform | ||
Identificaiton (IR) | IR | Same absorption bands as USP betadex sulfobutyl ether sodium RS. | Conform | |
HPLC | The retention time of the major peak of sample solution corresponds to the standard solution. | Conform | ||
Average degree of substitution | Conform | Conform | ||
Sodium | Identify test are positive for sodium. | |||
Assay | 95%-105% | 100.6% | ||
Betadex | ≤0.1% | Not detected | ||
1,4-butane sultone | ≤0.5ppm | 0.10ppm | ||
Sodium Chloride | ≤0.2% | 0.01% | ||
4-Hydroxybutane-l-sulfonic Acid | ≤0.09% | Not detected | ||
Bis-(4-sulfobtyl) ether disodium | ≤0.05% | 0.01% | ||
Bacterial endotoxins | ≤0.02EU/mg | <0.01EU/mg | ||
Average Degree of Substitution | 6.2-6.9 | 6.6 | ||
The total aerobic microbial count | ≤100cfu/g | <10cfu/g | ||
The total combined molds and yeasts count | ≤50cfu/g | <10cfu/g | ||
Escherichia Coli | Abesense | Not detected | ||
Clarity of solution | 30%(w/v) solution is clear and essentially free from particles of foreign matter | Conform | ||
Average degree of substitution | 6.2-6.9 | 6.6 | ||
Peaks I-X | Ⅰ | 0.0~0.3 | 0 | |
Ⅱ | 0.0~0.9 | 0.37 | ||
Ⅲ | 0.5~5.0 | 1.62 | ||
Ⅳ | 2.0~10.0 | 4.66 | ||
Ⅴ | 10.0~20.0 | 10.53 | ||
Ⅵ | 15.0~25.0 | 19.62 | ||
Ⅶ | 20.0~30.0 | 27.94 | ||
Ⅷ | 10.0~25.0 | 23.19 | ||
Ⅸ | 2.0~12.0 | 10.15 | ||
Ⅹ | 0.0~4.0 | 1.93 | ||
pH | 4.0~6.8 | 6.1 | ||
Water determination | ≤10.0% | 5.6% | ||










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