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KLEPTOSE® HPB Oral Grade Hydroxyprpyl Betadex - Pharma
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KLEPTOSE® HPB Oral Grade Hydroxyprpyl Betadex - Pharma

KLEPTOSE® HPB ORAL GRADE can be used to provide excipient benefits in many oral dosage applications. Hydroxypropyl beta-cyclodextrin can improve the solubility of poorly soluble compounds and can be used for taste masking of bitter or unpleasant active ingredients. It can also act as a stabilizer in these applications. Roquette has pioneered the industrial development of cyclodextrins with its KLEPTOSE® range of hydroxypropyl beta-cyclodextrins. These products are used in various oral dosage forms in both pharmaceutical and nutraceutical applications including swallowable tablets, chewable tablets, effervescent tablets, lozenges, hard capsules, soft capsules, orally dissolving films, blends, granules, pellets premix, medicated confectionary, syrups, suspensions, liquids, cream, paste and semi-solids.
Product Resources

Experts (2)

Knowde Enhanced TDS

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Identification & Functionality

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Features & Benefits

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Applications & Uses

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Properties

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Physical Form
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
Microbiological Values
ValueUnitsTest Method / Conditions
Escherichia ColiNot detected in 10g-EP
Molar Substitution0.62-EP / NF
Salmonella SpeciesNot detected in 10g-EP
Microbiological Values0.58 - 0.68-EP / NF
Total Aerobic Microbial Countmax. 1000CFU/gEP / NF
Total Yeasts and Moulds Countmax. 100CFU/gEP / NF
Color
White
Physical Form
Powder
Appearance
White or almost white amorphous or crystalline powder

Regulatory & Compliance

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Conformity

Conforms to the requirements of the current monograph 

  • European Pharmacopoeia (EP) HYDROXYPROPYLBETADEX (1804) 
  • National Formulary from USP-NF HYDROXYPROPYL BETADEX

Technical Details & Test Data

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Innovation Hub
Innovation Hub by Roquette
Looking for technical support or formulation inspiration? Visit Roquette’s Innovation Hub.

Storage & Handling

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Shelf Life
5 Years
Storage and Handling

The product durability may vary according to packaging type and manufacturing plant. Proper information is shown on labelling 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.

Documents (22)

Document Name
Type
Products
Technical Data Sheet
KLEPTOSE® HPB Oral Grade Hydroxyprpyl Betadex - Pharma
Technical Data Sheet
Products: KLEPTOSE® HPB Oral Grade Hydroxyprpyl Betadex - Pharma
Safety Data Sheet
KLEPTOSE® HPB Oral Grade Hydroxyprpyl Betadex - Pharma
Safety Data Sheet
Products: KLEPTOSE® HPB Oral Grade Hydroxyprpyl Betadex - Pharma
Safety Data Sheet
KLEPTOSE® HPB Oral Grade Hydroxyprpyl Betadex - Pharma
Safety Data Sheet
Products: KLEPTOSE® HPB Oral Grade Hydroxyprpyl Betadex - Pharma
Safety Data Sheet
KLEPTOSE® HPB Oral Grade Hydroxyprpyl Betadex - Pharma
Safety Data Sheet
Products: KLEPTOSE® HPB Oral Grade Hydroxyprpyl Betadex - Pharma
Safety Data Sheet
KLEPTOSE® HPB Oral Grade Hydroxyprpyl Betadex - Pharma
Safety Data Sheet
Products: KLEPTOSE® HPB Oral Grade Hydroxyprpyl Betadex - Pharma