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KLEPTOSE® HPB Biopharma Hydroxypropyl Betadex Cyclodextrin

KLEPTOSE® HPB Biopharma Hydroxypropyl Betadex Cyclodextrin is a low endotoxin grade materials that provides protein stabilization for biopharmaceutical downstream applications. With a hydrophobic internal cavity and hydrophilic exterior, KLEPTOSE® HPB BioPharma can encapsulate molecules, forming inclusion complexes where lipophilic compounds are non-covalently bound within the cavity. It is suitable for use in biopharmaceutical manufacturing and as an excipient for injectable dosage forms. Benefits Unique ability to encapsulate and shield water insoluble materials can be utilized to shield exposed hydrophobic residues on aggregation-prone proteins, thereby modulating protein aggregation Shows promise as a multifunctional excipient suitable for biopharma applications Can serve as a tool to synergistically complement biotherapeutic formulations Multicompendial material (EP, USP, JP) Features Starch derivative Cyclic oligosaccharide with a bucket-like structure

Brand: KLEPTOSE (15 products)

Chemical Name: (2-Hydroxypropyl)-β-cyclodextrin

Functions: Encapsulant, Stabilizer

Certifications & Compliance: European Pharmacopeia (Ph. Eur.), GMP, Japan Pharmacopeia (JP), United States Pharmacopeia (USP)

Labeling Claims: Pyrogen-free

Synonyms: 2-Hydroxypropyl-Beta-Cyclodextrin, beta-Cyclodextrin 2-Hydroxypropyl Ethers, HPBCD, HPbetaCD, HPCD, Hydroxypropyl Betadex, Hydroxypropyl-Beta-Cyclodextrin

Technical Data Sheet
Enhanced TDS

Enhanced TDS

Knowde-enriched technical product data sheet

Identification & Functionality

Chemical Family
Pharma & Nutraceuticals Functions
CAS No.
128446-35-5
EC No.
603-269-8
Chemical Structure

Roquette KLEPTOSE HPB Biopharma Hydroxypropyl Betadex Chemical Structure

Features & Benefits

Labeling Claims

Applications & Uses

Dosage Form
Manufacturing Technology
Application
KLEPTOSE® HPB for biopharma uses. It is a low endotoxin pyrogen-free solution for protein stabilization. It exhibits surface activity and anti-aggregation properties for therapeutic proteins shelf life extension. KLEPTOSE® HPB Biopharma also enables to reduce thermal and agitation sensitivity of formulations.

Properties

Physical Form
Appearance
Crystalline powder, White or almost white amorphous
Soluble in
Water, Propylene glycol
Typical Properties
ValueUnitsTest Method / Conditions
Any Other Impuritymax. 0.25%USP/NF
Bacterial Endotoxinsmax. 5IU/g-
Conductivitymax. 200microS/cmPh.Eur.-USP/NF
Impurity A: Beta Cyclodextrinmax. 1.5%Ph.Eur.-USP/NF
Impurity B: Propane 1,2 Diolmax. 2.5%Ph.Eur.-USP/NF
InfraredConforms-Ph.Eur.-USP/NF
Molar Substitution0.40 - 1.50-Ph.Eur.-USP/NF
Molar Substitution Nominal Value0.9--
Molecular Weight1387g/mol-
Propylene Oxidemax. 1mg/kgUSP/NF
Sum of Impurities Other Than Amax. 1.0%Ph.Eur.
Total of Other Impuritiesmax. 1%USP/NF
Water Content (LOD)4%-
Water Content (LOD)max. 10%-
Physico-Chemical Properties
ValueUnitsTest Method / Conditions
Loss on Dryingmax. 10.0%Ph.Eur.-USP/NF
Microbiological Values
ValueUnitsTest Method / Conditions
Escherichia coliNot detetcedper 10g-
PseudomonasNot detectedper 10g-
SalmonellaNot detectedper 10g-
Total Aerobic Microbial Countmax. 1000CFU/gPlate count
Total Yeasts and Moulds Countmax. 100CFU/g-
Note
  • (*) - Compliance data - Tests not performed
  • (**) - Monitoring plan
Solubility
Highly soluble in water. At high concentration, the wetting and dissolution time of the powder is delayed due to its low density and increased viscosity. Soluble in ethanol. Freely soluble in propylen glycol.

Regulatory & Compliance

Quality Standards
Conformity
Current pharmacopeias Ph.Eur.(1804) and U.S.P./N.F.

Technical Details & Test Data

Note
Methods used by Roquette may be Ph.Eur. or USP/NF or internal validated methods which have been compared to the pharmacopeia monograph.
Water Sorption Isotherm at 20°C

Roquette KLEPTOSE HPB Biopharma Hydroxypropyl Betadex Water Sorption Isotherm at 20°C

Glass Transition Temperature vs. Water Content

Roquette KLEPTOSE HPB Biopharma Hydroxypropyl Betadex Glass Transition Temperature vs. Water Content

Viscosity in Water

Roquette KLEPTOSE HPB Biopharma Hydroxypropyl Betadex Viscosity in Water

Surface Tension in Water

Roquette KLEPTOSE HPB Biopharma Hydroxypropyl Betadex Surface Tension in Water

Osmolality

Roquette KLEPTOSE HPB Biopharma Hydroxypropyl Betadex Osmolality

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Packaging & Availability

Packaging Type
Packaging Information
  • ROQ Product Code: 346113
  • Article (SKU) Code: 346113105E
  • Package Size & Type: 1 kg HDPE bottle

Storage & Handling

Storage & Shelf Life
  • Store in a dry area, preferably protected from wide humidity and temperature variations.
  • Retest Data Manufacturing date + 3 years in its original packaging.