PEARLITOL® Mannitol pharma range is used in pharmaceutical and nutraceutical formulations as a filler, filler/binder and bulk sweetener in oral dosage form applications.
Applications
- Swallowable, orally dispersible, chewable and effervescent tablets
- Lozenges
- Blends
- Granules
- Pellets premix
- Medicated confectionery
Features
- Unique blend of exceptional physical and chemical stability and no hygroscopicity
- Directly compressible crystalline range with various particle sizes
- Great organoleptic, non-cariogenic and sugar-free properties
- Suitable for use in formulations addressing pediatric and diabetic patient populations
Chemical Name: Mannitol
Function: Filler, Binder
Certifications & Compliance: EXCiPACT, United States Pharmacopeia (USP), ISO 9001, Japan Pharmacopeia (JP), GMP, FDA IID, Kosher, European Pharmacopeia (Ph. Eur.), Chinese Pharmacopeia (ChP), Halal
Labeling Claims: Halal, Kosher, Non-GMO, BSE-free, Vegan, TSE-free, Acrylamide-free
Product Resources
Knowde Enhanced TDS
Identification & Functionality
Chemical Name
CAS No.
69-65-8
Technologies
PEARLITOL® 100 SD Mannitol - Pharma Features & Benefits
Applications & Uses
Markets
Manufacturing Technology
Properties
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 |
Regulatory & Compliance
Grade
Conformity
Conforms to the requirements of the current monograph
- Chinese Pharmacopoeia (ChP) MANNITOL
Technical Details & Test Data
Innovation Hub
Innovation Hub
by Roquette
Looking for technical support or formulation inspiration? Visit
Roquette’s Innovation Hub.
Packaging & Availability
Packaging Information
- ROQ Product Code: 450310
- Article (SKU) Code: 450310105
- Package Size & Type: 20 kg lined cardboard 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 labelling 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.
Most Viewed Documents
Document Name
Type
Products