PEARLITOL® Mannitol pharma range is used in pharmaceutical and nutraceutical applications as a filler, filler/binder and bulk sweetener for various oral dosage forms.
Applications
- Swallowable, orally dispersible, chewable and effervescent tablets,
- Lozenges
- Blends
- Granules
- Pellets premix
- Medicated confectionery
Benefit
- Suitable for use in formulations addressing all types of patient populations, including pediatric and diabetic
Features
- Directly compressible
- Unique blend of exceptional physical and chemical stability
- No hygroscopicity
- Organoleptic, non-cariogenic and sugar-free properties
Chemical Name: Mannitol
Function: Filler, Binder, Sweetener
CAS Number: 87-78-5
Dosage Form: Orally Disintegrating Tablets (ODTs), Powder & Powder Blends, Tablets, Granules, Capsules
Labeling Claims: Sugar-free, Halal, Kosher, Melamine-free, Non-Carcinogenic, Vegan, Acrylamide-free
Synonyms: Manitol, Cordycepic Acid, Manicol, 1,2,3,4,5,6-Hexanehexol
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Popular Roquette Products
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PEARLITOL® 200 SD Mannitol - Pharma Binders & Disintegrants, Fillers & Diluents Oral
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PEARLITOL® 25 C Mannitol - Pharma Flavors & Taste Maskers, Fillers & Diluents, Binders & Disintegrants Oral, Nutraceuticals & Supplements
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Identification & Functionality
Chemical Name
CAS No.
EC No.
Technologies
PEARLITOL® 50 C Mannitol - Pharma Features & Benefits
Labeling Claims
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. 100 micron) | max. 25 | % | Laser |
| Particle Size Part (min. 20 micron) | max. 55 | % | Laser |
| Particle Size Part (min. 250 micron) | max. 5 | % | 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 | Not Detected | per 10g | EP |
| 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
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Technical Details & Test Data
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Packaging & Availability
Packaging Information
- ROQ Product Code: 450310
- Article (SKU) Code: 450310105
- Package Size & Type: 22.68 kg lined fiber drum
Storage & Handling
Shelf Life
PEARLITOL® 50 C Mannitol - Pharma
Roquette