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XYLISORB® 300 - Pharma
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Producer: 
Roquette
Brand: 
XYLISORB
XYLISORB® Xylitol powders can be used to provide excipient benefits including coatings, filler and filler/binder while providing nutrient benefits as a bulk sweetener. These benefits can be seen in various oral dosage forms in both pharmaceutical and nutraceutical applications including swallowable tablets and medicated confectionaries. Xylitol is a five-carbon polyol with a characteristic crystalline shape. XYLISORB® is particularly useful as a low calorie sugar-free ingredient that is known for its high natural sweetness. This makes it suitable to be used in formulation addressing all type of patient populations including pediatric and diabetic.

XYLISORB® 300 - Pharma

Producer: 
Roquette
Brand: 
XYLISORB
XYLISORB® Xylitol powders can be used to provide excipient benefits including coatings, filler and filler/binder while providing nutrient benefits as a bulk sweetener. These benefits can be seen in various oral dosage forms in both pharmaceutical and nutraceutical applications including swallowable tablets and medicated confectionaries. Xylitol is a five-carbon polyol with a characteristic crystalline shape. XYLISORB® is particularly useful as a low calorie sugar-free ingredient that is known for its high natural sweetness. This makes it suitable to be used in formulation addressing all type of patient populations including pediatric and diabetic.
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Properties

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Physical Form
Typical Properties
ValueUnitsTest Method / Conditions
Xylitol on DS98.0 - 102.0%EP
Xylitol on DS98.5 - 101.0%NF
Related Substancesmax. 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
Conductivitymax. 20microS/cmEP
Reducing Sugarmax. 0.2%EP/NF
Other Polyols (on DS)max. 2.0%NF
Lead Contentmax. 0.5mg/kgEP
Nickle Contentmax. 1mg/kgEP
Water Contentmax. 1%EP
Water Contentmax. 0.5%NF
Total Aerobic Microbial Countmax. 1000CFU/g
Total Yeast and Moulds Countmax. 100CFU/g
EscherichiaNot detected in 1g
SalmonellaNot detected in 10g
Physical Form
Soluble in
Water
Sparingly soluble in
Ethanol 96%

Regulatory & Compliance

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Regulatory Status
TSCA Listed (USA)
Conformity

Conforms to the requirements of the current monograph

- European Pharmacopoeia XYLITOL (1381)

- National Formulary from USP-NF XYLITOL

Storage & Handling

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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 labelling and CoA. We recommend to preserve the product in its unopened original packaging, preferably protected from wide variations of temperature and humidity.

Documents (22)

Name
Type
Roquette Quality Information Note-Vegan Vegetarian - EN
Other
Roquette Quality Certification GMO Lestrem Bureau Veritas - EN
Other
Roquette Quality Certification GMO - EN
Other
Roquette Quality Certification FSSC Lestrem - EN
Other
Roquette Quality Certification FDA Registration Number Europe
Other