产品名称:磺丁基β环糊精
指标规格
ITEMS | SPECIFICATION | RESULTS |
Appearance | White to off-white solid, free from foreign matter | Qualify |
Solution Clarity | A 30%w/v solution in water is clear and essentially free from particles of foreign matter | Qualify |
Identification (IR) | Consistent with SBECD standard | Qualify |
Sodium Identification | Identify test are positive for Sodium | + |
Average Degree of Substitution | 6.2-6.9 | 6.7 |
SBE 1 Content | ≤0.2% | 0.05% |
SBE 2 Content | ≤0.8% | 0.15% |
Water solution pH | pH of 30%w/v solution in water is 4.0-6.8 | 5.4 |
Heavy Metals | ≤5ppm | <5ppm |
Water | ≤10% | 4.0% |
β-Cyclodextrin Content | ≤0.1% | Absence |
Sodium Chloride | ≤0.2% | 0.01% |
1,4-butane sultone | ≤0.5ppm | 0.3ppm |
4-Hydroxybutane-1-Sulfonic Acid | ≤0.09% | 0.01% |
Disodium bis-(4-sulfobtyl) ether | ≤0.05% | 0.05% |
Assay | 95%-105% | 99.5% |
Bacterial endotoxins | ≤25EU/g | ≤20EU/g |
Microbiology | ||
Total viable aerobic count (mould plus yeast) | ≤100CFU/g | 20CFU/g |
Escherichia Coli | Absence | Absence |
Salmonella species | Absence | Absence |
mould plus yeast | ≤50CFU/g | Absence |
用途
磺丁基倍他环糊精钠是一种新型阴离子高水溶性环糊精衍生物,能很好地与药物分子包合形成非共价复合物,从而提高药物的稳定性、水溶性、安全性,降低肾毒性、缓和药物溶血性,控制药物释放速率,掩盖不良气味等。
目前已适用于注射药、口服药、鼻部用药、眼部用药,对于含氮类药物具有特殊的亲和力和包和性。
联系人:宋经理
手机/微信:13335219317
电话/传真:0533-4911647
地址:山东省淄博市博山区新博路6号
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