DMF No.: 030168
Name: hydroxypropyl- beta-cyclodextrin
Other name : hydroxypropyl betadex ; 2-hydroxypropyl-beta-cyclodextirn ;
Hydroxypropyl-β-cyclodextrin .
Abbreviation : HPBCD
CAS: 128446-35-5; 94035-02-6; 136019-12-0
EINECS: 420-920-1
Molecular formula :C42H70-nO35(C3H8O2)n
Molecular weight: 1134.98+58n
Qaulity ： Pharma grade / food grade / cosmetics grade / industry grade
Standard : USP39/ EP9.0/ CP2015
Package: 500g/bag , 2kg/bag, 10kg/drum , 20kg/drum or customized
Specification :
ITEMS
SPECIFICATION(USP39)
RESULTS
Appearance
white powder, insipid, innocent
Qualify
Assay
≥98％
99.5%
Degree of Substitution
2.8-10.5
5.5
Clarity of solution
50%(w/v) water solution is clear
clear
Identification(IR)
same absorption bands with USP Hydroxypropyl Betadex RS
Qualify
Loss on Drying
≤10％
4.5%
Conductivity
10%(w/v) water solution ≤200µS/cm
70
Propylene oxide
≤1ppm
＜0.18ppm
Propylene glycol
≤2.5％
0.05%
Sum of Other Impurities
≤1％
0.51%
Betadex
≤1.5%
0.39%
Residue on Ignition
≤0.2％
0.09%
Heavy Metal
≤20ppm
＜10ppm
chloride
≤0.05%
＜0.05%
Bacterial endotoxins
≤25EU/g
