Enhanced TDS
Knowde-enriched technical product data sheet
Identification & Functionality
- Chemical Name
- Pharma & Nutraceuticals Functions
- CAS No.
- 87-78-5
- EC No.
- 201-770-2
- Technologies
- Product Families
Features & Benefits
Applications & Uses
- Markets
- Applications
- Dosage Form
- Manufacturing Technology
Properties
- Physical Form
- Appearance
- White or almost white crystals or powder
- Soluble in
- Water
- Insoluble in
- Ethanol
- Typical Properties
Value Units Test Method / Conditions Conductivity max. 20 microS/cm EP / USP / JP D-Mannitol (on DS) 97.0 - 102.0 % EP / USP / JP Heavy Metals Content (Monitoring plan) max. 5 mg/kg JP Loss on Drying max. 0.5 % EP / USP / JP Melting Point 165 - 170 °C EP / USP / JP Nickel Content (Monitoring plan) max. 1 mg/kg USP / JP Particle Size Part (min. 140 micron Sympatec) max. 35 % Laser Particle Size Part (min. 150 micron Beckman) max. 35 % Laser Particle Size Part (min. 30 micron Sympatec) max. 70 % Laser Particle Size Part (min. 75 micron Beckman) max. 70 % Laser Reducing Sugars max. 0.1 % EP / USP / JP - Microbiological Values
Value Units Test Method / Conditions Escherichia coli (Monitoring plan) Not detected per gram EP / USP Salmonella Species (Monitoring plan) Not detected per 10g EP Total Aerobic Microbial Count max. 1000 CFU/g EP / USP Total Yeasts and Moulds Count max. 100 CFU/g EP / USP - Powder Characteristics
Value Units Test Method / Conditions Tapped Density 0.57 g/cm3 Powder Flowability (10mm outflow opening) 6.2 s Ph.Eur. 2.9.16 Bulk Density 0.47 g/cm3 True Density 1.514 g/cm3 Specific Surface Area 1.05 m²/g Angle of Repose 41 °
Regulatory & Compliance
- Certifications & Compliance
- Chemical Inventories
- Grade
- Conformity
Conforms to the requirements of the current monograph
- Chinese Pharmacopeia (ChP) MANNITOL
Technical Details & Test Data
- Innovation Hub
- Innovation Hub by RoquetteLooking for technical support or formulation inspiration? Visit Roquette’s Innovation Hub.
Packaging & Availability
- Packaging Information
- Article (SKU) Code: 5100001149
- Package Size & Type: 20 KG CARBOARD BOX
Storage & Handling
- Shelf Life
- 5 Years
- Storage and Handling
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.