XYLISORB XTAB® 400 Xylitol - Pharma

1 of 2 products in this brand
XYLISORB® Xylitol powders are used in coatings for pharmaceutical and nutraceutical formulations, and as a filler, filler/binder and bulk sweetener that provides nutrient benefits. Applications Swallowable tablets Medicated confectionery Features Five-carbon polyol with a characteristic crystalline shape Low-calorie, sugar-free ingredient with high natural sweetness Suitable for use in formulations addressing pediatric and diabetic patient populations

Chemical Name: Xylitol

Functions: Binder, Filler, Sweetener

Certifications & Compliance: EXCiPACT, European Pharmacopeia (Ph. Eur.), FDA Compliant, GMP, Halal, ISO 50001, ISO 9001, Kosher, United States Pharmacopeia (USP)

Labeling Claims: BSE-free, Halal, Kosher, Low Calorie, Melamine-free, Non-GMO, Non-Hazardous, Sugar-free, TSE-free, Vegan

Synonyms: Eutrit, Fluorette, L-Xylitol, Meso-Xylitol, Wood Sugar Alcohol, Xylisorb, Xylitab 100, Xylitab DC, Xylitol C

Knowde Enhanced TDS

Identification & Functionality

Chemical Family
Chemical Name
Pharma & Nutraceuticals Functions
EC No.
Chemical Structure

Roquette XYLISORB XTAB 400 Xylitol - Pharma Chemical Structure - 1


Roquette XYLISORB XTAB 400 Xylitol - Pharma Chemical Structure - 2

Features & Benefits

Applications & Uses

Dosage Form
Manufacturing Technology
XYLISORB® XTAB 400 / Xylitol granulated with maize dextrin is a direct compression excipient and bulk sweetener. It is used in pharmaceutical and nutraceutical applications including swallowable tablets, effervescent tablets and medicated confectionary.


Physical Form
Off - white and odourless powder Sweet and cool
Typical Properties
ValueUnitsTest Method / Conditions
Angle of Repose40Degree
Average Mean Particle Diameter400µm
Bulk Density0.5 - 0.7kg/l
Lead Content (**)max. 0.5mg/kg
pH Value (50% W/W)5.0 - 7.0
Mean Diameterapprox. 400microns
Melting Temperature (for xylitol)92 - 94°C
Na Carboxymethyl Cellulose (on DS)min. 1%
Particle Size Distribution by Laser Diffraction (dv10 %vol)158µm
Particle Size Distribution by Laser Diffraction (dv50 %vol)314µm
Particle Size Distribution by Laser Diffraction (dv90 %vol)567µm
Powder Flowability10.8secaccording to Ph.Eur. 2.9.16, 10mm outlow opening
Reducing Sugarsmax. 0.2%
Residue on 100 micronsmin. 90%
Residue on 800 micronsmax. 5%
Residue on Ignition (*)max. 1%
Specific Surface Areamax. 0.2m2/g
Tapped Density0.68g/cm3
True Density1.52g/cm3
Water Content (LOD)max. 0.5%
Xylitol on DSmin. 98%
Physico-Chemical Properties
ValueUnitsTest Method / Conditions
Nickel Content (*)max. 1mg/kg
Microbiological Values
ValueUnitsTest Method / Conditions
Escherichia coliNot detectedper gram
Salmonella (**)Not detectedper 10g
Total Aerobic Microbial Countmax. 1000CFU/gPlate count
Total Yeasts and Moulds Countmax. 100CFU/g
  • (*)-Compliance data - Tests not performed
  • (**)-Monitoring plan
Quantitative Composition
Approximately 98% of Xylitol / 2% of Sodium Carboxymethyl Cellulose
Very soluble in water (solubility of xylitol in water is 1 part of xylitol for 1.6 part of water at 20°C)

Regulatory & Compliance

Raw materials
  • XYLITOL European Pharmacopeia (1381) and National Formulary from USP-NF
  • SODIUM CARBOXYMETHYL CELLULOSE European Pharmacopeia (0472) and National Formulary from USP-NF

Technical Details & Test Data


Roquette XYLISORB XTAB 400 Xylitol - Pharma Morphology

  • Not intended for use in manufacture of parenteral dosage forms.
  • Methods used by Roquette may be the Pharmacopeia methods or alternative validated methods which have been compared to the Pharmacopeia methods.
Water Sorption Isotherm at 20°C

Roquette XYLISORB XTAB 400 Xylitol - Pharma Water Sorption Isotherm at 20°C

Compression Behavior

Roquette XYLISORB XTAB 400 Xylitol - Pharma Compression Behavior

Innovation Hub
Innovation Hub by Roquette
Looking for technical support or formulation inspiration? Visit Roquette’s Innovation Hub.

Packaging & Availability

Packaging Information
  • ROQ Product Code: 493404
  • Article (SKU) Code: 493404107E
  • Package Size & Type: 15 kg PE lined cardboard box

Storage & Handling

Storage & Shelf Life
    Expiry date Manufacturing date + 5 years, in its unopened packaging.
  • The product durability may vary according to packaging type and manufacturing plant. Proper information is shown on labeling 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.
  • Due to its fine particle size, this product is liable to become compacted.