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KLEPTOSE® HPB PARENTERAL GRADE
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Producer: 
Roquette
Brand: 
KLEPTOSE
KLEPTOSE® HPB Hydroxypropyl beta-cyclodextrin parenteral grade materials that are used as encapsulating agents for Rx injectables. These are modified beta-cyclodextrins for parenteral use. Modified beta-cyclodextrins used in parenteral preparations provide active substance stabilization improvement against light and oxidation as well as enhancement of solubilization of active pharmaceutical ingredients. Molecular encapsulation with modified beta-cyclodextrins has become an accepted and useful tool for pharmaceutical developers. There are currently several pharmaceutical products containing modified cyclodextrin complexes on the market. Roquette has pioneered the industrial development of cyclodextrins with its KLEPTOSE® range of beta-cyclodextrins. Hydroxypropyl betacyclodextrin (HPBCD) is a white, amorphous powder. The HPBCD molecule is a torus shaped ring with a polar hydrophilic outside and an apolar hydrophobic cavity.

KLEPTOSE® HPB PARENTERAL GRADE

Producer: 
Roquette
Brand: 
KLEPTOSE
KLEPTOSE® HPB Hydroxypropyl beta-cyclodextrin parenteral grade materials that are used as encapsulating agents for Rx injectables. These are modified beta-cyclodextrins for parenteral use. Modified beta-cyclodextrins used in parenteral preparations provide active substance stabilization improvement against light and oxidation as well as enhancement of solubilization of active pharmaceutical ingredients. Molecular encapsulation with modified beta-cyclodextrins has become an accepted and useful tool for pharmaceutical developers. There are currently several pharmaceutical products containing modified cyclodextrin complexes on the market. Roquette has pioneered the industrial development of cyclodextrins with its KLEPTOSE® range of beta-cyclodextrins. Hydroxypropyl betacyclodextrin (HPBCD) is a white, amorphous powder. The HPBCD molecule is a torus shaped ring with a polar hydrophilic outside and an apolar hydrophobic cavity.
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Experts (1)

Knowde Enhanced TDS

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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 - 1.50EP / 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
Microbiological Values
ValueUnitsTest Method / Conditions
Bacterial Endotoxinsmax.10EU/gEP / NF
Escherichia ColiNot detected in 10gEP
Molar Substitution0.62EP / NF
Molar Substitution0.58 - 0.68EP / NF
Salmonella SpeciesNot detected in 10gEP
Total Aerobic Microbial Countmax. 100CFU/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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Chemical Inventories
Regulatory Status
TSCA Listed (USA)
Conformity

Conforms to the requirements of the current monograph 

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

Storage & Handling

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Shelf Life
3 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)

Name
Type
Roquette Quality Information Note Contaminant Others Melamine - EN
Other
KLEPTOSE® HPB PARENTERAL GRADE Safety Data Sheet (REC - EN)
Safety Data Sheet
KLEPTOSE® HPB PARENTERAL GRADE Safety Data Sheet (REC - ES)
Safety Data Sheet
KLEPTOSE® HPB PARENTERAL GRADE Safety Data Sheet (REC - PT)
Safety Data Sheet
KLEPTOSE® HPB PARENTERAL GRADE Safety Data Sheet (US - EN)
Safety Data Sheet