PEARLITOL® Mannitol is used in pharmaceutical and nutraceutical formulations as a filler, filler/binder and bulk sweetener in various oral dosage 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, Orally Disintegrating Tablets (ODTs), Powder & Powder Blends, Tablets, Granules
Labeling Claims: Melamine-free, Kosher, BSE-free, Vegan, Halal, Sugar-free, Non-Carcinogenic, TSE-free, Non-GMO, Acrylamide-free
Certifications & Compliance: FSSAI, United States Pharmacopeia (USP), European Pharmacopeia (Ph. Eur.), Japan Pharmacopeia (JP), ISO 9001, FDA IID, EXCiPACT, Kosher, Chinese Pharmacopeia (ChP), Halal, FSSC 22000, GMP
Synonyms: 1,2,3,4,5,6-Hexanehexol , Cordycepic Acid , D-(-)-Mannitol , Manicol , Manitol
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TypeDocument Name
Safety Data Sheet
PEARLITOL® 200 SD Mannitol - Pharma Safety Data Sheet (REC - EN)
PEARLITOL® 200 SD Mannitol - Pharma Safety Data Sheet (REC - EN)
Safety Data SheetTechnical Data Sheet
PEARLITOL® 200 SD Technical Data Sheet
PEARLITOL® 200 SD Technical Data Sheet
Technical Data SheetSafety Data Sheet
PEARLITOL® 200 SD Mannitol - Pharma Safety Data Sheet (US - EN)
PEARLITOL® 200 SD Mannitol - Pharma Safety Data Sheet (US - EN)
Safety Data SheetSafety Data Sheet
PEARLITOL® 200 SD Mannitol - Pharma Safety Data Sheet (REC - ES)
PEARLITOL® 200 SD Mannitol - Pharma Safety Data Sheet (REC - ES)
Safety Data SheetSafety Data Sheet
PEARLITOL® 200 SD Mannitol - Pharma Safety Data Sheet (REC - PT)
PEARLITOL® 200 SD Mannitol - Pharma Safety Data Sheet (REC - PT)
Safety Data SheetKnowde Enhanced TDS
Identification & Functionality
Chemical Name
CAS No.
EC No.
Technologies
PEARLITOL® 200 SD Mannitol - Pharma Features & Benefits
Applications & Uses
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. 45 | % | Laser |
| Particle Size Part (min. 150 micron Beckman) | max. 45 | % | Laser |
| Particle Size Part (min. 30 micron Sympatec) | max. 90 | % | Laser |
| Particle Size Part (min. 300 micron Sympatec) | max. 10 | % | Laser |
| Particle Size Part (min. 315 micron Beckman) | max. 10 | % | Laser |
| Particle Size Part (min. 75 micron Beckman) | max. 90 | % | 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
- European Pharmacopeia (EP) MANNITOL (0559)
- US Pharmacopeia (USP) MANNITOL
- Japanese Pharmacopeia (JP) D-MANNITOL
Technical Details & Test Data
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Packaging & Availability
Packaging Information
- ROQ Product Code: 450320
- Article (SKU) Code: 450320117
- Package Size & Type: 25 kg polypropylene pail
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® 200 SD Mannitol - Pharma
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