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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
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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Identification & Functionality
Compendial Name
Pharma & Nutraceuticals Functions
CAS No.
87-99-0
Technologies
Features & Benefits
Labeling Claims
Ingredient Claims
Applications & Uses
Markets
Applications
Dosage Form
Properties
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 |
Soluble in
Water
Sparingly soluble in
Ethanol 96%
Regulatory & Compliance
Certifications & Compliance
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
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.
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