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倍他环糊精,Beta-Cyclodextrin,β-环糊精,BCD

倍他环糊精可用来制备多种药物分子的包合物,主要起到提高改善溶出和生物利用度的作用,可归因于溶解度的增加,以及化学和物理稳定性的提高。环糊精的包合物也用来掩盖活性物质的不良味道和将液体物质转化为固体材料。虽然β-环糊精的溶解性最差,但却是最常用的环糊精,也是最廉价的环糊精;但β-环糊精有肾毒性,不能用于注射剂;β-环糊精被认为口服无毒,主要用于片剂和胶囊剂的处方。

CAS No. : 7585-39-9
说明 : Native, Neutral
级别 : 药用级 Pharma Grade
品名 : 倍他环糊精,BCD,β-环糊精,Beta-Cyclodextrin
产地 : 匈牙利
包装 : 1kg/袋
CHEMICAL AND PHYSICAL DESCRIPTION
Molecular FormulaC42H70O35
Formula Weight1135.0
Possible impuritiesOther cyclodextrins, linear oligomers
Solubility
(in 100 cm3 solvent, at 25 °C)
Water: < 2.0 g
Methanol: < 1.0 g
DMSO: > 10 g
SPECIFICATION
TestMethodRange
AppearanceVisualwhite or almost white powder
Identification A: Specific optical rotationEP 2.2.7+160° to +164°
Identification B: HPLCEP 2.2.29conforms with reference
Identification C: Iodine test
yellow-brown precipitate
Appearance of 1% aqueous solutionVisual (EP 2.2.1)clear and colorless solution
pH of 1% aqueous solutionEP 2.2.35.0 - 8.0
Reducing sugars
max. 0.2%
Light absorbing impurities (1%)UV-Vis (EP 2.2.25)A230 - A350: max. 0.10
A350 - A750: max. 0.05
Related substances
residual ACD
residual GCD
sum of other impurities
HPLC (EP 2.2.29)
max. 0.25%
max. 0.25%
max. 0.50%
Residual solventsGC (EP 2.2.28)max. 10 ppm trichloroethylene
max. 10 ppm toluene
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
Sulphated ashEP 2.4.14max. 0.1%
BCD contentHPLC (EP 2.2.29)98.0 - 101.0%
Microbial contaminationEP 2.6.12, EP 2.6.13TAMC:<103 CFU/g
TYMC:<102 CFU/g
Salmonella: absent/10 g
E. Coli: absent/1 g
Loss on dryingEP 2.2.32max. 16.0%

Storage: at room temperature, in tightly closed container. 

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