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KLEPTOSE® HPB Parenteral Grade Hydroxypropyl Betadex
KLEPTOSE® HPB Hydroxypropyl beta-cyclodextrin parenteral grade materials that are used as encapsulating agents for Rx injectables. These are modified beta-cyclodextrins for parenteral use. Modified beta-cyclodextrins used in parenteral preparations provide active substance stabilization improvement against light and oxidation as well as enhancement of solubilization of active pharmaceutical ingredients. Molecular encapsulation with modified beta-cyclodextrins has become an accepted and useful tool for pharmaceutical developers. There are currently several pharmaceutical products containing modified cyclodextrin complexes on the market. Roquette has pioneered the industrial development of cyclodextrins with its KLEPTOSE® range of beta-cyclodextrins. Hydroxypropyl betacyclodextrin (HPBCD) is a white, amorphous powder. The HPBCD molecule is a torus shaped ring with a polar hydrophilic outside and an apolar hydrophobic cavity.
Knowde Enhanced TDS
Identification & Functionality
Chemical Family
Chemical Name
Pharma & Nutraceuticals Functions
CAS No.
128446-35-5
Technologies
Features & Benefits
Labeling Claims
Applications & Uses
Markets
Properties
Color
White
Appearance
White or almost white amorphous or crystalline powder
Typical Properties
| Value | Units | Test Method / Conditions | |
| Conductivity | max. 200 | micros/cm | EP / NF |
| Loss on Drying | max. 10.0 | % | EP / NF |
| Molar Substitution | 0.40 - 1.50 | - | EP / NF |
| Particle Size (Residue on 100 micron) | min. 50 | % | Sieve |
| Particle Size (Residue on 315 micron) | max. 20 | % | Sieve |
| Propylene Oxide (Monitoring Plan) | max. 0.0001 | % | NF |
Microbiological Values
| Value | Units | Test Method / Conditions | |
| Bacterial Endotoxins | max.10 | EU/g | EP / NF |
| Escherichia Coli | Not detected in 10g | - | EP |
| Escherichia Coli | Not Detected | 10g | EP |
| Molar Substitution | 0.62 | - | EP / NF |
| Molar Substitution | 0.58 - 0.68 | - | EP / NF |
| Salmonella Species | Not detected in 10g | - | EP |
| Salmonella | Not Detected | 10g | EP |
| Total Aerobic Microbial Count | max. 100 | CFU/g | EP / NF |
| Total Yeasts and Moulds Count | max. 100 | CFU/g | EP / NF |
Regulatory & Compliance
Certifications & Compliance
Chemical Inventories
Conformity
Conforms to the requirements of the current monograph
- European Pharmacopoeia (EP) HYDROXYPROPYLBETADEX (1804)
- National Formulary from USP-NF HYDROXYPROPYL BETADEX
Technical Details & Test Data
Innovation Hub
Innovation Hub
by Roquette
Looking for technical support or formulation inspiration? Visit
Roquette’s Innovation Hub.
Packaging & Availability
Packaging Information
- ROQ Product Code: 346111
- Article (SKU) Code: 346111109
- Package Size & Type: 1 kg HDPE bottle
Storage & Handling
Shelf Life
3 Years
Storage and Handling
The product durability may vary according to packaging type and manufacturing plant. Proper information is shown on labelling and CoA. We recommend to preserve the product in its unopened original packaging, preferably protected from wide variations of temperature and humidity. Upon opening, use the product as quickly as possible to prevent moisture regain
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