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XYLISORB® 300 Xylitol - Pharma

XYLISORB® Xylitol powders can be used in pharmaceutical and nutraceutical applications as a filler, filler/binder and bulk sweetener that provides nutrient benefits. Applications Swallowable tablets Medicated confectionaries 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

Brand: XYLISORB (4 products)

Chemical Name: Xylitol

CAS Number: 87-99-0

Dosage Form: Granules, Sachets, Stick, Suspension, Syrups, Tablets

Labeling Claims: Halal, Kosher, Low Calorie, Non-GMO, Sugar-free, Vegan, Vegetarian

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

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

Technical Data Sheet Safety Data Sheet

Enhanced TDS

Knowde-enriched technical product data sheet

Identification & Functionality

Chemical Name: Xylitol
Pharma & Nutraceuticals Functions: Binder,
Coating System,
Filler,
Film Former,
Sweetener
CAS No.: 87-99-0
EC No.: 201-788-0
Technologies: Pharmaceuticals & Nutraceuticals
Product Families: Pharmaceuticals & Nutraceuticals — Excipients
Binders & Disintegrants,
Fillers & Diluents,
Flavors & Taste Maskers,
Pharmaceutical Coatings

Features & Benefits

Labeling Claims: Halal,
Kosher,
Low Calorie,
Non-GMO,
Sugar-free,
Vegan,
Vegetarian

Applications & Uses

Markets: Healthcare & Pharma
Applications: Healthcare & Pharma — Drug Delivery & Care Solutions
Oral
Dosage Form: Granules,
Sachets,
Stick,
Suspension,
Syrups,
Tablets

Properties

Physical Form

Soluble in

Water

Sparingly soluble in

Ethanol 96%

Typical Properties


	Value	Units	Test Method / Conditions
Xylitol on DS	98.0 - 102.0	%	EP
Xylitol on DS	98.5 - 101.0	%	NF
Related Substances	max. 2.0	%	EP
Particle Size (Residue on 500 microns)	max. 2	%	Sieve Analysis
Particle Size (Residue on 315 microns)	max. 20	%	Sieve Analysis
Particle Size (Residue on 100 microns)	min. 60	%	Sieve Analysis
Conductivity	max. 20	microS/cm	EP
Reducing Sugar	max. 0.2	%	EP/NF
Other Polyols (on DS)	max. 2.0	%	NF
Lead Content	max. 0.5	mg/kg	EP
Nickle Content	max. 1	mg/kg	EP
Water Content	max. 1	%	EP
Water Content	max. 0.5	%	NF
Total Aerobic Microbial Count	max. 1000	CFU/g
Total Yeast and Moulds Count	max. 100	CFU/g
Escherichia	Not detected in 1g
Salmonella	Not detected in 10g

Regulatory & Compliance

Certifications & Compliance: EXCiPACT,
European Pharmacopeia (Ph. Eur.),
GMP,
Halal,
ISO 50001,
ISO 9001,
Japan Pharmacopeia (JP),
Kosher,
United States Pharmacopeia (USP)
Grade: Pharma Grade
Quality Standards: ICH Q7
Conformity: Conforms to the requirements of the current monograph

- European Pharmacopeia XYLITOL (1381)

- National Formulary from USP-NF XYLITOL

Packaging & Availability

Packaging Information

ROQ Product Code: 493302
Article (SKU) Code: 493302104
Package Size & Type: 25 kg lined cardboard box

Storage & Handling

Storage and Handling: 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.