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94035-02-6 Hydroxypropyl-Beta-Cyclodextrin Pharmaceuticals
About us
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Product name
Hydroxypropyl-beta-cyclodextrin CAS:94035-02-6
Packaging, Storage &Shelf Life
Package
1kg/bag,25kg/ drum
Storage
Stored in original packaging for two years at a temperature not exceeding 40°C.
Shelf life
2 years if sealed and stored properly.
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 |
≤20EU/g |
<20EU/g |
TAMC(cfu/g) |
≤1000 |
<10 |
TYMC(cfu/g) |
≤100 |
<10 |
Salmonella/E. Coli (cfu/g) |
Absent |
Absent |
Function
Hydroxypropyl beta cyclodextrin is a solution to insoluble or low solubility drugs(including plant extracts).Through molecular encapsulation,it could increase the drug solubility and control the release rate of the drug,increase the drug's bioavailability and reduce the toxic side-effets.
1. Suitable for parenteral use, syrups, solutions and oral suspensions as well as for dry formulations (with possibility of in-situ encapsulation).
2. To increase water solubility of poorly soluble drugs.
3. To increase bioavailability.
4. To improve organoleptic properties of bitter or unpleasant actives.
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