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KLEPTOSE® HPB Oral Grade Hydroxypropyl Betadex - Pharma

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Chemical Name: (2-Hydroxypropyl)-β-cyclodextrin
Function: Taste Masker, Stabilizer, Solubilizer
Certifications & Compliance: Halal, FSSC 22000, EXCiPACT, United States Pharmacopeia (USP), FSSAI, ISO 9001, GMP, FDA IID, Kosher, European Pharmacopeia (Ph. Eur.)
Labeling Claims: Halal, Kosher, Non-GMO, BSE-free, Vegan, TSE-free, Acrylamide-free
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TypeDocument Name
Safety Data Sheet
KLEPTOSE® HPB ORAL GRADE Safety Data Sheet (US - EN)
KLEPTOSE® HPB ORAL GRADE Safety Data Sheet (US - EN)
Safety Data Sheet
Safety Data Sheet
KLEPTOSE® HPB ORAL GRADE Safety Data Sheet (REC - EN)
KLEPTOSE® HPB ORAL GRADE Safety Data Sheet (REC - EN)
Safety Data Sheet
Safety Data Sheet
KLEPTOSE® HPB ORAL GRADE Safety Data Sheet (REC - ES)
KLEPTOSE® HPB ORAL GRADE Safety Data Sheet (REC - ES)
Safety Data Sheet
Technical Data Sheet
KLEPTOSE® HPB ORAL GRADE Technical Data Sheet
KLEPTOSE® HPB ORAL GRADE Technical Data Sheet
Technical Data Sheet
Safety Data Sheet
KLEPTOSE® HPB ORAL GRADE Safety Data Sheet (REC - PT)
KLEPTOSE® HPB ORAL GRADE Safety Data Sheet (REC - PT)
Safety Data Sheet

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Identification & Functionality

KLEPTOSE® HPB Oral Grade Hydroxypropyl Betadex - Pharma 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 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

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: 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 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 Oral Grade Hydroxypropyl Betadex - Pharma
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