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XYLISORB XTAB® 240 Xylitol - Pharma

1 of 2 products in this brand
XYLISORB® Xylitol powders can be used as a low calorie, sugar-free ingredient that provides high natural sweetness. A five-carbon polyol with a characteristic crystalline shape, it provides excipient benefits as a coating, filler and filler/binder and nutrient benefits as a bulk sweetener. It can be used: in pharmaceutical and nutraceutical oral dosage applications, including swallowable tablets and medicated confectioneries in formulations addressing all types of patient populations, including pediatric and diabetic

Chemical Name: Dextrin, Xylitol

Functions: Binder, Filler, Sweetener

Certifications & Compliance: EXCiPACT, European Pharmacopeia (Ph. Eur.), FSSC 22000, GMP, Halal, ISO 9001, Kosher, United States Pharmacopeia (USP)

Labeling Claims: Halal, Kosher, Non-Carcinogenic, Sugar-free, Vegan

Technical Data SheetSafety Data Sheet

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Identification & Functionality

Chemical Name

Dextrin,

Xylitol

Pharma & Nutraceuticals Functions

Binder,

Filler,

Sweetener

Technologies

Pharmaceuticals & Nutraceuticals

Product Families

Pharmaceuticals & Nutraceuticals — Excipients

Binders & Disintegrants,

Fillers & Diluents,

Flavors & Taste Maskers

Features & Benefits

Labeling Claims

Halal,

Kosher,

Non-Carcinogenic,

Sugar-free,

Vegan

Applications & Uses

Markets

Healthcare & Pharma

Applications

Healthcare & Pharma — Drug Delivery & Care Solutions

Oral

Dosage Form

Tablets

Manufacturing Technology

Direct Compression

Properties

Physical Form

Powder,

Solid

Odor
Odorless
Appearance
White Powder
Sparingly soluble in
Ethanol
Typical Properties
ValueUnitsTest Method / Conditions
Bulk Densityapprox.0.5 kg/l—
Physico-Chemical Properties
ValueUnitsTest Method / Conditions
Arsenic Contentmax. 3ppmMCL
Heavy Metals Contentmax.10ppmMCL
Lead Contentmax. 1ppmMCL
Maize Dextrin (/DS)approx. 5%MCL
Particle Size (Residue on 100 microns)max. 80%MCL
Particle Size (Residue on 500 microns)max. 1%MCL
Reducing Sugarsmax. 0.5%MCL
Nickel Contentmax. 1ppmMCL
SO₂ Contentmax. 10ppmMCL
Water Contentmax. 1%MCL
Xylitol (/DS)93 - 97%MCL
Microbiological Values
ValueUnitsTest Method / Conditions
Escherichia coliAbsentper gramMMC
SalmonellaAbsentper 25gMMC
Salmonella SpeciesAbsentper 25gMMC
Total Aerobic Microbial Countmax.1000per gramMMC
Total Yeasts and Moulds Countmax.100per gramMMC

Regulatory & Compliance

Certifications & Compliance

EXCiPACT,

European Pharmacopeia (Ph. Eur.),

FSSC 22000,

GMP,

Halal,

ISO 9001,

Kosher,

United States Pharmacopeia (USP)

Grade

Pharma Grade

Technical Details & Test Data

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Packaging & Availability

Packaging Information
  • ROQ Product Code: 493403
  • Article (SKU) Code: 493403107
  • Package Size & Type: 25 kg polypropylene pail

Storage & Handling

Shelf Life
36 months
Storage and Handling

Standard packaging

25 kg polyethylene in cardboard box. Store at room temperature, in a dry place, and in its unopened original packaging.