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磺丁基醚-β-环糊精

产品名称:磺丁基β环糊精

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指标规格

ITEMSSPECIFICATIONRESULTS
AppearanceWhite to off-white solid, free from foreign matterQualify
Solution ClarityA 30%w/v solution in water is clear and essentially free from particles of foreign matterQualify
Identification (IR)Consistent with SBECD standardQualify
Sodium IdentificationIdentify test are positive for Sodium+
Average Degree of Substitution6.2-6.96.7
SBE 1 Content≤0.2%0.05%
SBE 2 Content≤0.8%0.15%
Water solution pHpH of 30%w/v solution in water is 4.0-6.85.4
Heavy Metals≤5ppm<5ppm
Water≤10%4.0%
β-Cyclodextrin Content≤0.1%Absence
Sodium Chloride≤0.2%0.01%
1,4-butane sultone≤0.5ppm0.3ppm
4-Hydroxybutane-1-Sulfonic Acid≤0.09%0.01%
Disodium bis-(4-sulfobtyl) ether≤0.05%0.05%
Assay95%-105%99.5%
Bacterial endotoxins≤25EU/g≤20EU/g
Microbiology
Total viable aerobic count (mould plus yeast)≤100CFU/g20CFU/g
Escherichia ColiAbsenceAbsence
Salmonella speciesAbsenceAbsence
mould plus yeast≤50CFU/gAbsence


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。