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KLEPTOSE® HPB Parenteral Grade Hydroxypropyl Betadex

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KLEPTOSE® HPB Parenteral Grade Hydroxypropyl Betadex

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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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
Color
White
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
Microbiological Values
ValueUnitsTest Method / Conditions
Bacterial Endotoxinsmax.10EU/gEP / NF
Escherichia ColiNot detected in 10g-EP
Escherichia ColiNot Detected10gEP
Molar Substitution0.62-EP / NF
Molar Substitution0.58 - 0.68-EP / NF
Salmonella SpeciesNot detected in 10g-EP
SalmonellaNot Detected10gEP
Total Aerobic Microbial Countmax. 100CFU/gEP / NF
Total Yeasts and Moulds Countmax. 100CFU/gEP / NF

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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Packaging & Availability

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Packaging Information
  • ROQ Product Code: 346111
  • Article (SKU) Code: 346111109
  • Package Size & Type: 1 kg HDPE bottle

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

Most Viewed Documents

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Document Name
Type
Products
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KLEPTOSE® HPB PARENTERAL GRADE Safety Data Sheet (REC - EN)
Safety Data Sheet
KLEPTOSE® HPB Parenteral Grade Hydroxypropyl Betadex
Safety Data Sheet
Products: KLEPTOSE® HPB Parenteral Grade Hydroxypropyl Betadex
KLEPTOSE® HPB PARENTERAL GRADE Technical Data Sheet
Technical Data Sheet
KLEPTOSE® HPB Parenteral Grade Hydroxypropyl Betadex
Technical Data Sheet
Products: KLEPTOSE® HPB Parenteral Grade Hydroxypropyl Betadex
Roquette Quality Certification HALAL MUI Pantnagar - EN
Other
XYLISORB XTAB® 240 Xylitol - Pharma, KLEPTOSE® HPB Oral Grade Hydroxyprpyl Betadex - Pharma, KLEPTOSE® HPB Parenteral Grade Hydroxypropyl Betadex, MICROCEL® MC-101 Microcrystalline Cellulose - Pharma, MICROCEL® MC-102 Microcrystalline Cellulose - Pharma, SOLUTAB® A Croscarmellose Sodium - Pharma, PEARLITOL® 50 C Mannitol - Pharma, LYCATAB® C Partially Pregalatinized Starch - Pharma, LYCATAB® PGS Pregelatinized Starch - Pharma, PEARLITOL® 100 SD Mannitol - Pharma, PEARLITOL® 200 SD Mannitol - Pharma, PEARLITOL® 300 DC Mannitol - Pharma
Other
Products: XYLISORB XTAB® 240 Xylitol - Pharma, KLEPTOSE® HPB Oral Grade Hydroxyprpyl Betadex - Pharma, KLEPTOSE® HPB Parenteral Grade Hydroxypropyl Betadex, MICROCEL® MC-101 Microcrystalline Cellulose - Pharma, MICROCEL® MC-102 Microcrystalline Cellulose - Pharma, SOLUTAB® A Croscarmellose Sodium - Pharma, PEARLITOL® 50 C Mannitol - Pharma, LYCATAB® C Partially Pregalatinized Starch - Pharma, LYCATAB® PGS Pregelatinized Starch - Pharma, PEARLITOL® 100 SD Mannitol - Pharma, PEARLITOL® 200 SD Mannitol - Pharma, PEARLITOL® 300 DC Mannitol - Pharma
Roquette Quality Certification ISO 9001 Gokak - EN
Other
XYLISORB XTAB® 240 Xylitol - Pharma, KLEPTOSE® HPB Oral Grade Hydroxyprpyl Betadex - Pharma, KLEPTOSE® HPB Parenteral Grade Hydroxypropyl Betadex, MICROCEL® MC-101 Microcrystalline Cellulose - Pharma, MICROCEL® MC-102 Microcrystalline Cellulose - Pharma, SOLUTAB® A Croscarmellose Sodium - Pharma, PEARLITOL® 50 C Mannitol - Pharma, LYCATAB® C Partially Pregalatinized Starch - Pharma, LYCATAB® PGS Pregelatinized Starch - Pharma, PEARLITOL® 100 SD Mannitol - Pharma, PEARLITOL® 200 SD Mannitol - Pharma, PEARLITOL® 300 DC Mannitol - Pharma
Other
Products: XYLISORB XTAB® 240 Xylitol - Pharma, KLEPTOSE® HPB Oral Grade Hydroxyprpyl Betadex - Pharma, KLEPTOSE® HPB Parenteral Grade Hydroxypropyl Betadex, MICROCEL® MC-101 Microcrystalline Cellulose - Pharma, MICROCEL® MC-102 Microcrystalline Cellulose - Pharma, SOLUTAB® A Croscarmellose Sodium - Pharma, PEARLITOL® 50 C Mannitol - Pharma, LYCATAB® C Partially Pregalatinized Starch - Pharma, LYCATAB® PGS Pregelatinized Starch - Pharma, PEARLITOL® 100 SD Mannitol - Pharma, PEARLITOL® 200 SD Mannitol - Pharma, PEARLITOL® 300 DC Mannitol - Pharma
Roquette Quality Certification HALAL Wuhan
Other
XYLISORB XTAB® 240 Xylitol - Pharma, KLEPTOSE® HPB Oral Grade Hydroxyprpyl Betadex - Pharma, KLEPTOSE® HPB Parenteral Grade Hydroxypropyl Betadex, MICROCEL® MC-101 Microcrystalline Cellulose - Pharma, MICROCEL® MC-102 Microcrystalline Cellulose - Pharma, SOLUTAB® A Croscarmellose Sodium - Pharma, PEARLITOL® 50 C Mannitol - Pharma, LYCATAB® C Partially Pregalatinized Starch - Pharma, LYCATAB® PGS Pregelatinized Starch - Pharma, PEARLITOL® 100 SD Mannitol - Pharma, PEARLITOL® 200 SD Mannitol - Pharma, PEARLITOL® 300 DC Mannitol - Pharma
Other
Products: XYLISORB XTAB® 240 Xylitol - Pharma, KLEPTOSE® HPB Oral Grade Hydroxyprpyl Betadex - Pharma, KLEPTOSE® HPB Parenteral Grade Hydroxypropyl Betadex, MICROCEL® MC-101 Microcrystalline Cellulose - Pharma, MICROCEL® MC-102 Microcrystalline Cellulose - Pharma, SOLUTAB® A Croscarmellose Sodium - Pharma, PEARLITOL® 50 C Mannitol - Pharma, LYCATAB® C Partially Pregalatinized Starch - Pharma, LYCATAB® PGS Pregelatinized Starch - Pharma, PEARLITOL® 100 SD Mannitol - Pharma, PEARLITOL® 200 SD Mannitol - Pharma, PEARLITOL® 300 DC Mannitol - Pharma
Roquette Quality Information Note Contaminant Others Melamine - EN
Other
XYLISORB XTAB® 240 Xylitol - Pharma, KLEPTOSE® HPB Oral Grade Hydroxyprpyl Betadex - Pharma, KLEPTOSE® HPB Parenteral Grade Hydroxypropyl Betadex, PEARLITOL® 50 C Mannitol - Pharma, LYCATAB® C Partially Pregalatinized Starch - Pharma, LYCATAB® PGS Pregelatinized Starch - Pharma, PEARLITOL® 100 SD Mannitol - Pharma, PEARLITOL® 200 SD Mannitol - Pharma, PEARLITOL® 300 DC Mannitol - Pharma
Other
Products: XYLISORB XTAB® 240 Xylitol - Pharma, KLEPTOSE® HPB Oral Grade Hydroxyprpyl Betadex - Pharma, KLEPTOSE® HPB Parenteral Grade Hydroxypropyl Betadex, PEARLITOL® 50 C Mannitol - Pharma, LYCATAB® C Partially Pregalatinized Starch - Pharma, LYCATAB® PGS Pregelatinized Starch - Pharma, PEARLITOL® 100 SD Mannitol - Pharma, PEARLITOL® 200 SD Mannitol - Pharma, PEARLITOL® 300 DC Mannitol - Pharma
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