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KLEPTOSE® HPB Parenteral Grade Hydroxypropyl Betadex Cyclodextrin

1 of 15 products in this brand
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

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

CAS Number: 128446-35-5

Functions: Encapsulant, Solubilizer, Stabilizer

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)

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

Technical Data SheetSafety Data Sheet

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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

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 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 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