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KLEPTOSE® HPB Parenteral Grade Hydroxypropyl Betadex Cyclodextrin

KLEPTOSE® HPB Hydroxypropyl Betadex Cyclodextrin 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

Brand: KLEPTOSE (4 products)

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

CAS Number: 128446-35-5

Dosage Form: Injectables

Labeling Claims: Acrylamide-free, Halal, Kosher, Non-GMO, Pyrogen-free, Vegan

Certifications & Compliance: European Pharmacopeia (Ph. Eur.), FSSAI, FSSC 22000, Halal, ISO 9001, Kosher, United States Pharmacopeia (USP)

Manufacturing Technology: Encapsulation

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

Technical Data SheetSafety Data Sheet

Enhanced TDS

Knowde-enriched technical product data sheet

Identification & Functionality

Chemical Family
Cyclodextrins
Chemical Name
(2-Hydroxypropyl)-β-cyclodextrin
Pharma & Nutraceuticals Functions
Encapsulant,
Solubilizer,
Stabilizer
CAS No.
128446-35-5
EC No.
603-269-8
Technologies
Pharmaceuticals & Nutraceuticals
Product Families
Pharmaceuticals & Nutraceuticals — Excipients
Emulsifiers & Stabilizers,
Modified & Controlled Release,
Solvents & Solubilizers

Features & Benefits

Labeling Claims
Acrylamide-free,
Halal,
Kosher,
Non-GMO,
Pyrogen-free,
Vegan

Applications & Uses

Markets
Healthcare & Pharma
Applications
Healthcare & Pharma — Drug Delivery & Care Solutions
Parenteral
Dosage Form
Injectables
Manufacturing Technology
Encapsulation

Properties

Physical Form
Powder,
Solid
Appearance
White or almost white amorphous or crystalline powder
Typical Properties
ValueUnitsTest Method / Conditions
Conductivitymax. 200micros/cmEP / NF
Loss on Dryingmax. 10.0%EP / NF
Molar Substitution0.40 - 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
ValueUnitsTest Method / Conditions
Molar Substitution0.62-EP / NF
Molar Substitution0.58 - 0.68-EP / NF
Microbiological Values
ValueUnitsTest Method / Conditions
Bacterial endotoxinsmax.10EU/gEP / NF
Escherichia coliNot detetcedper 10gEP
Escherichia coliNot Detectedper 10gEP
SalmonellaNot Detectedper 10gEP
Total Aerobic Microbial Countmax. 100CFU/gEP / NF
Total Yeasts and Moulds Countmax. 100CFU/gEP / NF

Regulatory & Compliance

Certifications & Compliance
European Pharmacopeia (Ph. Eur.),
FSSAI,
FSSC 22000,
Halal,
ISO 9001,
Kosher,
United States Pharmacopeia (USP)
Chemical Inventories
TSCA (USA)
Grade
Pharma 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 Type
Drums
Packaging Information
  • Article (SKU) Code: 5900000003
  • Package Size & Type: 1 KG 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 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