Knowde Enhanced TDS
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
- Labeling Claims
Applications & Uses
- Applications
- 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
- Taste
- Slightly sweet
- Appearance
- White or almost white crystalline powder
- Soluble in
- Water
- Insoluble in
- Ethanol (96%)
- Typical Properties
- Physico-Chemical Properties
- Microbiological Values
- Powder Characteristics
- 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
| 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 |
| 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 |
| 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 |
| 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 | ° | — |
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