Enhanced TDS
Knowde-enriched technical product data sheet
Identification & Functionality
- Chemical Family
- Chemical Name
- Pharma & Nutraceuticals Functions
- CAS No.
- 50-70-4
- EC No.
- 200-061-5
- Technologies
- Product Families
- Chemical Structure
Features & Benefits
Applications & Uses
- Markets
- Applications
- Dosage Form
- Manufacturing Technology
- Application
- NEOSORB® P 300 SD sorbitol is a direct compression excipient. It is a non-cariogenic and non-acidogenic sugar-free sweetener that is suitable for chewable, suckable or effervescent tablets
Properties
- Physical Form
- Taste
- Slightly sweet
- Appearance
- White or almost white crystalline powder
- Soluble in
- Very soluble in water (235 g/100ml at 25°C)
- Insoluble in
- Practically insoluble in ethanol (96%)
- Typical Properties
Value Units Test Method / Conditions Acidity Complies - JP Amount of Related Substance max. 3.0 % EP pH Value 3.5 - 7.0 - NF Average Mean Particle Diameter 300 µm - Chlorides Content max. 50 mg/kg JP Conductivity max. 20 microS/cm EP Dsorbitol on DS 91.0 - 100.5 % NF Dsorbitol on DS 97.0 - 102.0 % EP Glucose Content max. 6.3 ml JP Heavy Metals Content (*) 5 mg/kg JP Identification Test A Complies - EP Identification Test A (*) Complies - NF Identification Test B Complies - NF Identification Test 1 (*) Complies - JP Identification Test 2 (*) Complies - JP Identification Test 3 (*) Complies - JP Impurity A: D-mannitol max. 2.0 % EP Impurity B: D-iditol max. 2.0 % EP Impurity C: D-maltitol max. 2.0 % EP Loss on Drying (*) max. 2.0 % JP Melting Temperature 95 - 98 °C - Molecular Weight 182.17 g/mol - Particle Size Distribution by Laser Diffraction (dv10) 156 µm - Particle Size Distribution by Laser Diffraction (dv50) 304 µm - Particle Size Distribution by Laser Diffraction (dv90) 530 µm - Reducing Sugars max. 0.2 % EP Reducing Sugars max. 0.3 % NF Residue on 100 microns min. 95 % - Residue on 500 microns max. 5 % - Residue on Ignition max. 0.02 % JP Residue on Ignition max. 0.1 % NF Sugar Content max. 6.3 ml JP Sulfates Content max. 60 mg/kg JP Water Content max. 1.5 % EP / NF - Physico-Chemical Properties
Value Units Test Method / Conditions Arsenic Content max. 1.3 % JP Assay Content (on DS) min. 97.0 % JP Nickel Content (*) Complies - JP Nickel Content (*) max. 1 mg/kg NF - Microbiological Values
Value Units Test Method / Conditions Escherichia coli (**) Not detected per gram EP Salmonella (**) Not detected per 10g EP Total Aerobic Microbial Count (**) max. 1000 CFU/g Ep / Nf Total Yeasts and Moulds Count(**) max. 100 CFU/g EP / NF - Powder Characteristics
Value Units Test Method / Conditions Powder Flowability 7 S according to Ph.Eur. 2.9.16, 10mm outflow opening Bulk Density 0.53 g/cm³ Tapped Density 0.57 g/cm3 True Density 1.507 g/cm3 Specific Surface Area 2.1 m²/g Angle of Repose 43 ° - Note
- "EP" stands for European Pharmacopeia
- "NF" stands for National Formulary from USP-NF
- "JP" stands for Japanese Pharmacopeia
- (*)-Compliance data - Tests not performed
- (**)-Monitoring plan
Regulatory & Compliance
- Certifications & Compliance
- Chemical Inventories
- Grade
- Conformity
- Conforms to the requirements of the current monograph
- European Pharmacopeia SORBITOL (0435)
- National Formulary from USP-NF SORBITOL
- Japanese Pharmacopeia D-SORBITOL Please contact us for any statement regarding compliance to the General Chapters (elemental impurities, residual solvents, organic volatile impurities, metal catalyst, metal reagent).
Technical Details & Test Data
- 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.
- Morphology
- Experimental Conditions for Compression Behavior
Tablet Press STYLCAM 200R Production Speed 25 tablets/min (linear punch velocity: 96 mm/s; simulated rotary press speed: approximately 150000 tablets/hour) Tooling Diameter 10 mm R9 Concave Lubrication 0.5% magnesium stearate Tablet Mass 400 mg - Water Sorption Isotherm at 20°C
- Compression Behaviour
- Innovation Hub
- Innovation Hub by RoquetteLooking for technical support or formulation inspiration? Visit Roquette’s Innovation Hub.
Packaging & Availability
- Packaging Information
- ROQ Product Code: 423221
- Article (SKU) Code: 423221101
- Package Size & Type: 15 kg PE lined cardboard box
Storage & Handling
- Storage & Shelf Life
- Expiry Date Manufacturing date + 5 years, in its unopened packaging.
- Those date is indicative and 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