Product Name: (2-HYDROXYPROPYL)-BETA-CYCLODEXTRIN CAS: 128446-35-5 Natural/Synthetic: Synthesis Appearance: white powder Packing: 10KG/cardboard drum Ingredients: Betacyclodextrin with 1,2-epoxypropane etherate. Calculated on anhydrous basis, with hydroxypropoxyl (a OCH2CHOHCH3) should be 19.6% -26.3%. Physicochemical properties: White crystalline powder, odorless, slightly sweet, odorless, slightly sweet taste; Moisture-relieving strong molecular formula: C63H112O42 Molecular Weight: 1541.54 Melting point: 278°C Solubility: This product is easily soluble in water and soluble in methanol. Or ethanol, practically insoluble in acetone or chloroform Field: Solubilizers and Excipients Deferred products: injections, tablets Application: Solubilizers and tablet excipients for injections
(2-HYDROXYPROPYL)-BETA-CYCLODEXTRIN Certificate of Anlysis
Product name
Hydroxypropyl-beta-cyclodextrin
CAS No.
128446-35-5
Outer Packing
10KG/drum
Production date
2017.12.06
Shelf life
2019.12.05
Standard adopted
USP39-NF34
Items of analysis
Specification
Results
Appearance
white powder, insipid, innocent
Qualify
Degree of Substitution
0.40-1.50
0.77
Clarity of solution
50%(w/v) water solution is clear
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Identification(IR)
same absorption bands with USP Hydroxypropyl Betadex RS
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Loss on Drying
≤10％
3.9%
Conductivity
10%(w/v) water solution ≤200µS/cm
60
Propylene oxide
≤1ppm
0.18ppm
Propylene glycol
≤2.5％
0.35%
Sum of Other Impurities
≤1％
0.10%
Betadex
≤1.5%
0.11%
Residue on Ignition
≤0.2％
0.039%
Heavy Metal
≤20ppm
＜20ppm
chloride
≤0.05%
＜0.05%
Total number of colonies
≤1000 cfu/g
70cfu/g
Total yeast
≤100 cfu/g
30cfu/g
Total pathogenic bacteria
Absent
Absent
Conclusion
Qualified
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