KLEPTOSE® HPB Parenteral Grade Hydroxypropyl Betadex
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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
CAS Number: 128446-35-5
Labeling Claims: Kosher, Vegan, Non-GMO, Pyrogen-free, Acrylamide-free, Halal
Certifications & Compliance: FSSC 22000, FSSAI, United States Pharmacopeia (USP), European Pharmacopeia (Ph. Eur.), Halal, ISO 9001, Kosher
Synonyms: HPbetaCD, beta-Cyclodextrin 2-Hydroxypropyl Ethers, Hydroxypropyl Betadex, Hydroxypropyl-Beta-Cyclodextrin, 2-Hydroxypropyl-Beta-Cyclodextrin, HPBCD, HPCD
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KLEPTOSE® HPB Biopharma Hydroxypropyl Betadex Modified & Controlled Release, Emulsifiers & Stabilizers Parenteral
TypeDocument Name
Safety Data Sheet
KLEPTOSE® HPB PARENTERAL GRADE Safety Data Sheet (REC - EN)
KLEPTOSE® HPB PARENTERAL GRADE Safety Data Sheet (REC - EN)
Safety Data SheetTechnical Data Sheet
KLEPTOSE® HPB PARENTERAL GRADE Technical Data Sheet
KLEPTOSE® HPB PARENTERAL GRADE Technical Data Sheet
Technical Data SheetSafety Data Sheet
KLEPTOSE® HPB PARENTERAL GRADE Safety Data Sheet (US - EN)
KLEPTOSE® HPB PARENTERAL GRADE Safety Data Sheet (US - EN)
Safety Data SheetSafety Data Sheet
KLEPTOSE® HPB PARENTERAL GRADE Safety Data Sheet (REC - ES)
KLEPTOSE® HPB PARENTERAL GRADE Safety Data Sheet (REC - ES)
Safety Data SheetSafety Data Sheet
KLEPTOSE® HPB PARENTERAL GRADE Safety Data Sheet (REC - PT)
KLEPTOSE® HPB PARENTERAL GRADE Safety Data Sheet (REC - PT)
Safety Data SheetKnowde Enhanced TDS
Identification & Functionality
Chemical Family
Chemical Name
Pharma & Nutraceuticals Functions
CAS No.
EC No.
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 Pharmacopeia (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
Storage and Handling
The product durability may vary according to packaging type and manufacturing plant. Proper information is shown on labeling 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
KLEPTOSE® HPB Parenteral Grade Hydroxypropyl Betadex
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