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XYLISORB XTAB® 240 Xylitol - Pharma

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

Brand: XYLISORB XTAB (2 products)

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 Sheet Safety Data Sheet

Enhanced TDS

Knowde-enriched technical product data sheet

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

Odor

Odorless

Appearance

White Powder

Sparingly soluble in

Ethanol

Typical Properties


	Value	Units	Test Method / Conditions
Bulk Density	approx.0.5	kg/l	-

Physico-Chemical Properties


	Value	Units	Test Method / Conditions
Arsenic Content	max. 3	ppm	MCL
Heavy Metals Content	max.10	ppm	MCL
Lead Content	max. 1	ppm	MCL
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 Sugars	max. 0.5	%	MCL
Nickel Content	max. 1	ppm	MCL
SO₂ Content	max. 10	ppm	MCL
Water Content	max. 1	%	MCL
Xylitol (/DS)	93 - 97	%	MCL

Microbiological Values


	Value	Units	Test Method / Conditions
Escherichia coli	Absent	per gram	MMC
Salmonella	Absent	per 25g	MMC
Salmonella Species	Absent	per 25g	MMC
Total Aerobic Microbial Count	max.1000	per gram	MMC
Total Yeasts and Moulds Count	max.100	per gram	MMC

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

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: 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.