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: D-mannitol
Function: Filler, Binder
CAS Number: 69-65-8
Dosage Form: Capsules, Tablets, Orally Disintegrating Tablets (ODTs)
Labeling Claims: Kosher, TSE-free, BSE-free, Vegan, Non-GMO, Acrylamide-free, Halal
Certifications & Compliance: Chinese Pharmacopeia (ChP), United States Pharmacopeia (USP), European Pharmacopeia (Ph. Eur.), Halal, Japan Pharmacopeia (JP), ISO 9001, FDA IID, EXCiPACT, Kosher, GMP
Synonyms: 1,2,3,4,5,6-Hexanehexol , Cordycepic Acid , D-(-)-Mannitol , Manicol , Manitol
Start Order
SecureOrder Quantity
Price
Available upon quote
Minimum Order Quantity
Quote required
Lead Time
Quote required
Available Incoterms
Quote required
Regional Availability
Quote required
Ask Roquette Questions
Ask the Supplier
Popular Roquette Products
View All Roquette Products PEARLITOL® 200 SD Mannitol - Pharma
PEARLITOL® 50 C Mannitol - Pharma
PEARLITOL® 400 DC
TypeDocument Name
Safety Data Sheet
PEARLITOL® 100 SD Mannitol - Pharma Safety Data Sheet (REC - EN)
PEARLITOL® 100 SD Mannitol - Pharma Safety Data Sheet (REC - EN)
Safety Data SheetTechnical Data Sheet
PEARLITOL® 100 SD Technical Data Sheet
PEARLITOL® 100 SD Technical Data Sheet
Technical Data SheetSafety Data Sheet
PEARLITOL® 100 SD Mannitol - Pharma Safety Data Sheet (US - EN)
PEARLITOL® 100 SD Mannitol - Pharma Safety Data Sheet (US - EN)
Safety Data SheetSafety Data Sheet
PEARLITOL® 100 SD Mannitol - Pharma Safety Data Sheet (REC - ES)
PEARLITOL® 100 SD Mannitol - Pharma Safety Data Sheet (REC - ES)
Safety Data SheetSafety Data Sheet
PEARLITOL® 100 SD Mannitol - Pharma Safety Data Sheet (REC - PT)
PEARLITOL® 100 SD Mannitol - Pharma Safety Data Sheet (REC - PT)
Safety Data SheetKnowde Enhanced TDS
Identification & Functionality
Chemical Name
CAS No.
EC No.
Technologies
PEARLITOL® 100 SD Mannitol - Pharma Features & Benefits
Applications & Uses
Markets
Manufacturing Technology
Properties
Appearance
Soluble in
Insoluble in
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 Pharmacopeia (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
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.
PEARLITOL® 100 SD Mannitol - Pharma
Roquette