Enhanced TDS
Knowde-enriched technical product data sheet
Identification & Functionality
- Chemical Family
- Chemical Name
- Pharma & Nutraceuticals Functions
- CAS No.
- 87-99-0
- EC No.
- 201-788-0
- Technologies
- Product Families
- Chemical Structure
Features & Benefits
Applications & Uses
- Markets
- Applications
- Dosage Form
- Manufacturing Technology
- Application
- 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.
Properties
- Physical Form
- Taste
- Sweet
- Appearance
- Off - white and odourless powder Sweet and cool
- Typical Properties
Value Units Test Method / Conditions Angle of Repose 40 Degree - Average Mean Particle Diameter 400 µm - Bulk Density 0.5 - 0.7 kg/l - Lead Content (**) max. 0.5 mg/kg - pH Value (50% W/W) 5.0 - 7.0 - - Mean Diameter approx. 400 microns - Melting Temperature (for xylitol) 92 - 94 °C - Na Carboxymethyl Cellulose (on DS) min. 1 % - Particle Size Distribution by Laser Diffraction (dv10 %vol) 158 µm - Particle Size Distribution by Laser Diffraction (dv50 %vol) 314 µm - Particle Size Distribution by Laser Diffraction (dv90 %vol) 567 µm - Powder Flowability 10.8 sec according to Ph.Eur. 2.9.16, 10mm outlow opening Reducing Sugars max. 0.2 % - Residue on 100 microns min. 90 % - Residue on 800 microns max. 5 % - Residue on Ignition (*) max. 1 % - Specific Surface Area max. 0.2 m2/g - Tapped Density 0.68 g/cm3 - True Density 1.52 g/cm3 - Water Content (LOD) max. 0.5 % - Xylitol on DS min. 98 % - - Physico-Chemical Properties
Value Units Test Method / Conditions Nickel Content (*) max. 1 mg/kg - - Microbiological Values
Value Units Test Method / Conditions Escherichia coli Not detected per gram - Salmonella (**) Not detected per 10g - Total Aerobic Microbial Count max. 1000 CFU/g Plate count Total Yeasts and Moulds Count max. 100 CFU/g - - Note
- (*)-Compliance data - Tests not performed
- (**)-Monitoring plan
- Quantitative Composition
- Approximately 98% of Xylitol / 2% of Sodium Carboxymethyl Cellulose
- Solubility
- 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
- Certifications & Compliance
- Grade
- Conformity
- 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
- Morphology
- Note
- 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
- Compression Behavior
- Innovation Hub
- Innovation Hub by RoquetteLooking 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.