Enhanced TDS
Knowde-enriched technical product data sheet
Identification & Functionality
- Chemical Family
- Chemical Name
- Pharma & Nutraceuticals Functions
- CAS No.
- 87-78-5
- EC No.
- 201-770-2
- Technologies
- Product Families
- Chemical Structure
Features & Benefits
Applications & Uses
- Markets
- Applications
- Dosage Form
- Manufacturing Technology
Properties
- Physical Form
- Odor
- Odorless, Slight sweetness
- Appearance
- White or almost white crystalline powder
- Taste
- Cooling effect, Pleasant taste
- Soluble in
- Very soluble in water (216 mg/ml at 25 °C)
- Insoluble in
- Practically in ethanol
- Typical Properties
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 % - - Physico-Chemical Properties
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 - 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
- "ChP" stands for Chinese Pharmacopeia
- (*)-Compliance data - Tests not performed
- (**)-Monitoring plan
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.