PEARLITOL® 100 SD
Mannitol
Product Profile

PEARLITOL® 100 SD
Mannitol

EP/USP/JP/CHP compliance

 

Product Name

PEARLITOL® 100 SD Mannitol   

Synonyms

D-Mannitol

CAS Number

69-65-8

Chemical Structure

Molecular Weight

182.17 g/mol

Physical Form or Appearence

White or almost white crystalline powder

Application

PEARLITOL® 100 SD / Mannitol is a 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)

Maximum water content: 3 %

Morphology

Average Mean Particle Diameter

100 µm

Particle Size Distribution by Laser Diffraction

dv10 = 16.5 µm
dv50 = 100 µm
dv90 = 165 µm

Solubility

Freely soluble in water (1 part in 5.5), sparingly soluble in 95% ethanol (1 part in 83), practically insoluble in ether

Melting Temperature

166-170°C

Water sorption isotherm at 20°C

Taste/Odor

Slightly sweet (sweetening power about 70% that of sucrose) and with a slight cooling effect.

Compression Behaviour

Experimental Conditions for Compression Behavior

Tablet Press  STYLCAM 200R 
Production Speed  25 tablets/min (linear punch velocity: 96 mm/s; simulated rotary press speed: approximately 150000 tablets/hour) 
Tooling  10 mm R9 Concave 
Lubrication  1.2% Magnesium stearate 
Tablet Mass  400 mg 

Powder Characteristics

Powder Flowability: 6.2 s (according to Ph.Eur. 2.9.16, 10mm outflow opening)
Bulk Density: 0.47 g/cm3
Tapped Density: 0.57 g/cm3
True Density: 1.514 g/cm3
Specific Surface Area: 1.05 m²/g
Angle of Repose: 41°