PEARLITOL® 400 DC
Mannitol
Product Profile

PEARLITOL® 400 DC
Mannitol

Product Name PEARLITOL® 400 DC
Generic Name Mannitol
Physico-chemical properties
Compliance EP/USP-NF/JP/CHP
Synonyms D-Mannitol
CAS Number 69-65-8
Chemical Structure
Average Molecular Weight 182.2 g/mol
Physical Form or Appearence White or almost white crystalline powder
Application PEARLITOL® 400 DC mannitol is a high density, direct compression excipient. It is a non-cariogenic and non-acidogenic sugar-free sweetener with exceptional physical and chemical stability and no hygroscopicity. It is suitable in formulations addressing all types of patient populations including pediatric and diabetic. It can be used in lozenges, swallowable tablets, orally dispersible tablets, chewable tablets and effervescent tablets.
Water content (LOD)

Water Content (LOD) Maximum: 0.5 %

Morphology
Average mean particle diameter 400 µm
Particle Size Distribution by Laser Diffraction

dv10: 205 µm

dv50: 400 µm

dv90: 615 µm

Solubility Freely soluble in water (1 part in 5.5 part of water at 20°C), sparingly soluble in 95% ethanol (1 part in 83), practically insoluble in ether
Melting temperature

Minimum melting temperature : 166 °C

Maximum melting temperature: 170 °C

Water sorption isotherm at 20°C
Taste/Odor Slightly sweetness and cooling effect.
Tablet hardness
Experimental Conditions for Compression Behavior

Tablet Press: STYLCAM 200R

Production Speed: 10, 25 and 40 tablets/min (respective linear punch velocity: 38, 96 and 152 mm/s ; respective simulated rotary press speed: 60000, 150000 and 250000 tablets/hour)

Tooling: Diameter 10 mm flat

Formula: 98.8% PEARLITOL® 400 DC / 1.2% magnesium stearate

Tablet Mass: 450 mg

Powder Characteristics

Powder Flowability (according to Ph.Eur. 2.9.16, 10mm outflow opening): 7 s

Bulk Density: 0.69 g/cm3

Tapped Density: 0.8 g/cm3

True Density: 1.514 g/cm3

Specific surface area: 0.45 m2/g

Angle of Repose: 29 °

 

Disclaimer

These typical values are provided for information only and we believe them to be reliable. Methods available upon request.

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