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KLEPTOSE® HPB Oral Grade Hydroxypropyl Betadex Cyclodextrin - Pharma

KLEPTOSE® HPB Oral Grade is a solubilizer and stabilizer for pharmaceutical and nutraceutical oral dosage applications. Applications Swallowable, chewable and effervescent tablets Lozenges Hard and soft capsules Orally dissolving films Blends Granules Pellets premix Medicated confectionary Syrups Suspensions Liquids Cream Paste Semi-solids Benefits Improves the solubility of poorly soluble compounds Can be used for taste masking of bitter or unpleasant active ingredients

Brand: KLEPTOSE (4 products)

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

CAS Number: 128446-35-5

Dosage Form: Capsules, Creams, Films, Granules, Injectables, Lozenges, Orally Disintegrating Tablets (ODTs), Pellets, Powder & Powder Blends, Suspension, Syrups, Tablets

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

Certifications & Compliance: EXCiPACT, European Pharmacopeia (Ph. Eur.), FDA IID, FSSAI, FSSC 22000, GMP, 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

Enhanced TDS

Knowde-enriched technical product data sheet

Identification & Functionality

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

Features & Benefits

Labeling Claims
Acrylamide-free,
BSE-free,
Halal,
Kosher,
Non-GMO,
TSE-free,
Vegan

Applications & Uses

Markets
Healthcare & Pharma
Applications
Healthcare & Pharma — Drug Delivery & Care Solutions
Oral,
Parenteral,
Topical
Dosage Form
Capsules,
Creams,
Films,
Granules,
Injectables,
Lozenges,
Orally Disintegrating Tablets (ODTs),
Pellets,
Powder & Powder Blends,
Suspension,
Syrups,
Tablets

Properties

Physical Form
Powder,
Solid
Appearance
White or almost white amorphous or crystalline powder
Soluble in
Water, Ethanol, Propylene Glycol
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 315 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
Microbiological Values
ValueUnitsTest Method / Conditions
Escherichia coliNot detetcedper 10gEP
SalmonellaNot detectedper 10gEP
Total Aerobic Microbial Countmax. 1000CFU/gEP / NF
Total Yeasts and Moulds Countmax. 100CFU/gEP / NF
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 propylene glycol.

Regulatory & Compliance

Certifications & Compliance
EXCiPACT,
European Pharmacopeia (Ph. Eur.),
FDA IID,
FSSAI,
FSSC 22000,
GMP,
Halal,
ISO 9001,
Kosher,
United States Pharmacopeia (USP)
Chemical Inventories
TSCA (USA)
Grade
Pharma Grade
Quality Standards
ICH Q7
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
  • ROQ Product Code: 346112
  • Article (SKU) Code: 346112102
  • Package Size & Type: 2 kg HDPE bottle

Storage & Handling

Shelf Life
5 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.