Knowde Enhanced TDS
Identification & Functionality
- Chemical Family
- Chemical Name
- CAS No.
- 87-78-5
- EC No.
- 201-770-2
- Technologies
- Product Families
- Chemical Structure
Features & Benefits
Applications & Uses
- Applications
- Dosage Form
- Manufacturing Technology
Properties
- Odor
- Odorless, Slight sweetness
- Appearance
- White or almost white crystalline powder
- Taste
- Cooling effect, Pleasant taste
- Soluble in
- Water
- Insoluble in
- Ethanol
- Typical Properties
- Physico-Chemical Properties
- Microbiological Values
- Note
- "ChP" stands for Chinese Pharmacopeia
- (*)-Compliance data - Tests not performed
- (**)-Monitoring plan
| Value | Units | Test Method / Conditions | |
| Acidity | Complies | — | ChP |
| Average Mean Particle Diameter | 25 | µm | — |
| Bulk Density | 0.48 | g/ml | — |
| Specific Optical Rotation | +137° to + 145° | Degree | ChP |
| Chlorides Content | 30 | mg/kg | ChP |
| Clarity and Color of Solution | Complies | — | ChP |
| Heavy Metals Content (*) | max. 10 | mg/kg | ChP |
| Identification Test 1 (*) | Complies | — | ChP |
| Identification Test 2 (*) | Complies | — | ChP |
| Melting Point | 166 - 170 | °C | ChP |
| Melting Temperature | 169 | °C | — |
| Molecular Weight | 182.2 | g/mol | — |
| Oxalate Content (*) | max. 0.0002 | % | ChP |
| Particle Size (Laser, min. 75 microns) | max. 10 | % | — |
| Particle Size Distribution by Laser Diffraction (dv10) | 3.5 | µm | — |
| Particle Size Distribution by Laser Diffraction (dv50) | 24 | µm | — |
| Particle Size Distribution by Laser Diffraction (dv90) | 55 | µm | — |
| Reducing Sugars | Complies | — | ChP |
| Residue on Ignition | max. 0.001 | — | ChP |
| Specific Surface Area | 0.8 | m²/g | — |
| Sulfates Content | 100 | mg/kg | ChP |
| Tapped Density | 0.74 | g/ml | — |
| Total Impurities | max. 2.0 | % | ChP |
| True Density | 1.514 | g/ml | — |
| Water Content (LOD) | max. 0.5 | % | — |
| Value | Units | Test Method / Conditions | |
| Arsenic Content | max. 2 | mg/kg | ChP |
| Assay Content (on DS) | 98.0 - 102.0 | % | ChP |
| Loss on Drying | max. 0.5 | % | ChP |
| 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 | — |
Regulatory & Compliance
- Certifications & Compliance
- Chemical Inventories
- Grade
- Conformity
- Conforms to the requirements of the current monograph
- Chinese Pharmacopeia (ChP) MANNITOL 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
- 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
- Innovation Hub
- Innovation Hub by RoquetteLooking for technical support or formulation inspiration? Visit Roquette’s Innovation Hub.
Packaging & Availability
- Packaging Information
- ROQ Product Code: 450012
- Article (SKU) Code: 450012981T
- Package Size & Type: 25 kg lined strippable paper bag
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.