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羟丙基倍他环糊精, (2-Hydroxypropyl)-Beta-Cyclodextrin (DS~4.5),HPBCD,羟丙基-B-环糊精,HP-B-CD

外观形状:白色结晶性粉末、无毒、无嗅、微甜。在医药工业中,由于相对表面活性和溶血活性比较低且对肌肉没有刺激性,所以它是一种理想的注射剂增溶剂和药物赋形剂。可以提高难溶性药物的水溶性,增加药物稳定性、提高药物生物利用度,使药剂的疗效增加或服用量减少,可以调整或控制药物的释放速度,降低药物毒副作用。可用于口服药物、注射剂、粘膜给药系统、透皮吸收给药系统、亲脂性靶向药物的载体,还可用做蛋白质的保护剂和稳定剂。给药途径:注射给药,口服制剂,眼、鼻、直肠和皮肤给药。禁忌:水溶液中,环糊精的存在可能导致有些抗菌防腐剂的活性降低。

CAS No. : 128446-35-5
说明 : Randomly Substituted Cyclodextrins, Neutral
级别 : 药用级 Pharma Grade
品名 : 羟丙基倍他环糊精, HPBCD,(2-Hydroxypropyl)-Beta-Cyclodextrin (DS~4.5),羟丙基-β-环糊精,HP-β-CD
产地 : 匈牙利
包装 : 电询
CHEMICAL AND PHYSICAL DESCRIPTION
Average Molecular FormulaC42H70-nO35 · (C3H7O)n
Average Formula Weight1135.0 + n·(58.1)
Possible impuritiesPropylene glycol, beta-cyclodextrin, hydroxypropylated linear dextrins
Solubility
(in 100 cm3 solvent, at 25 °C)
Water: > 33 g
Methanol: > 33 g
DMF: > 33 g
SPECIFICATION
TestMethodRange
AppearanceVisualwhite or almost white, amorphous or crystalline powder
Identification AIR (EP 2.2.24)complies with reference standard
Identification B  (Appearance of solution)EP 2.2.1, EP 2.2.2 Method II1 g dissolved in 2 mL of water with heating is clear and colorless and remains so after cooling
Conductivity (25 °C, 1% solution in water)EP 2.2.38max. 200 µS/cm
Related substances
residual BCD
propylene glycol
total other impurities

HPLC (EP 2.2.29)
GC (EP 2.2.28)
HPLC (EP 2.2.29)

max. 1.5%
max. 2.5%
max. 1.0%
Heavy metalsEP 2.4.20Cd  max. 0.2 ppm
Pb  max. 0.5 ppm
As  max. 1.5 ppm
Hg  max. 0.3 ppm
Co max. 0.5 ppm
V   max. 1 ppm
Ni  max. 2 ppm
Average Degree of Substitution (n)NMR (EP 2.2.33)2.8 - 10.5 (molar substitution: 0.4 - 1.5)
Microbial contaminationEP 2.6.12, EP 2.2.13TAMC: max. 103 CFU/g
TYMC: max. 102 CFU/g
Salmonella: absent/10 g
E.Coli: absent/1 g
Bacterial endotoxin (if intended for parenteral use)EP 2.6.14<10 IU/g
Loss on dryingEP 2.2.32max. 10.0%

Storage: at room temperature, in tightly closed container. 

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