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0 Metric Ton |
Negotiable |
Dexolve-4 SBECD low DS Captisol
Test
Method | Result | |
Appearance | Visual | white or off-white powder |
Identification | CE (USP <1053>) | meets the requirements of average degree of substitution |
Purity |
Calculated (on dry substance) |
> 95% |
Limit of BCD (Betadex) | HPLC (USP <621>) | NMT 1.5% on the anhydrous basis |
Limit of 1,4-butane sultone | GC (USP <621>) | NMT 5 ppm |
Limit of 4-hydroxybutane-1-sulfonic acid | CE (USP <1053>) | NMT 2.5% |
Limit of bis(4-sulfobutyl) ether disodium | CE (USP <1053>) | NMT 0.05% |
Clarity of solution (30%, w/v) | Visual | the solution is clear, and essentially free from particles of foreign matter |
Average Degree of Substitution (n) | CE (USP <1053>) | 3.5 - 4.5 |
pH (30%, w/v ) | USP <791> | 4.0 - 6.8 |
Phosphate content | USP <851> | 125 - 300 μg/g |
Water content | USP <921> Method I | NMT 10.0% |
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