KLEPTOSE® HPB Hydroxypropyl is a modified beta-cyclodextrin parenteral grade material that can be used as an encapsulating agent for Rx injectables.
Benefits
- Improves stabilization of active substances against light and oxidation
- Enhances solubilization of active pharmaceutical ingredients
Features
- White, amorphous powder
- Molecule is a torus-shaped ring with a polar hydrophilic outside and an apolar hydrophobic cavity
Chemical Name: (2-Hydroxypropyl)-β-cyclodextrin
Function: Stabilizer, Solubilizer, Encapsulant
Certifications & Compliance: United States Pharmacopeia (USP), FSSAI, ISO 9001, Kosher, European Pharmacopeia (Ph. Eur.), Halal, FSSC 22000
Labeling Claims: Kosher, Non-GMO, Pyrogen-free, Vegan, Acrylamide-free, Halal
Product Resources
Knowde Enhanced TDS
Identification & Functionality
Chemical Family
Chemical Name
Pharma & Nutraceuticals Functions
CAS No.
128446-35-5
Technologies
KLEPTOSE® HPB Parenteral Grade Hydroxypropyl Betadex Features & Benefits
Labeling Claims
Applications & Uses
Markets
Manufacturing Technology
Properties
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 |
Physico-Chemical Properties
| Value | Units | Test Method / Conditions | |
| Molar Substitution | 0.62 | - | EP / NF |
| Molar Substitution | 0.58 - 0.68 | - | EP / NF |
Microbiological Values
| Value | Units | Test Method / Conditions | |
| Bacterial endotoxins | max.10 | EU/g | EP / NF |
| Escherichia coli | Not detetced | per 10g | EP |
| Escherichia coli | Not Detected | per 10g | EP |
| Salmonella | Not Detected | per 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
Grade
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
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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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