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KLEPTOSE® HPB Parenteral Grade Hydroxypropyl Betadex

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Chemical Name: (2-Hydroxypropyl)-β-cyclodextrin
Function: Stabilizer, Solubilizer, Encapsulant
Certifications & Compliance: United States Pharmacopeia (USP), FSSAI, ISO 9001, Kosher, European Pharmacopeia (Ph. Eur.), Halal, FSSC 22000
Labeling Claims: Kosher, Non-GMO, Pyrogen-free, Vegan, Acrylamide-free, Halal
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Samantha LeTechnical Expert at RoquettePlease reach out to me with any questions, I am happy to assist you in finding the right product or learning more about our storefront.
Please reach out to me with any questions, I am happy to assist you in finding the right product or learning more about our storefront.

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Identification & Functionality

KLEPTOSE® HPB Parenteral Grade Hydroxypropyl Betadex Features & Benefits

Applications & Uses

Properties

Physical Form
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

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

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 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

KLEPTOSE® HPB Parenteral Grade Hydroxypropyl Betadex
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