PEARLITOL® 400 DC
Mannitol
Product Profile

PEARLITOL® 400 DC
Mannitol

Product Name PEARLITOL® 400 DC
Generic Name Mannitol Directly Compressible
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 offers high API compatibility and no hygroscopicity. It is also a non-cariogenic and non-acidogenic sugar-free sweetener. 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 : 165 °C

Maximum melting temperature: 170 °C

Water sorption isotherm at 20°C
Taste/Odor Slightly sweet 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

® Registered trademark(s) of Roquette Frères. Any information provided herein is intended for healthcare and food industry professionals for internal use only and not to be delivered as such to final consumers. Information is based on our current state of knowledge and made available on an informational basis; products described may have restrictions with respect to their use, communication, and/or usage levels, and such may vary on a country-by-country basis. Manufacturers of dietary supplements should evaluate the intended use of the particular ingredient in their finished dietary supplement to confirm compliance with the applicable laws and regulations of authorities regulating such products, because the suitability and regulatory status of a product may be dependent on its specific intended use. As the use of these products is beyond our control, Roquette makes no express or implied warranties regarding the use of the product and no guarantee of product properties, and in particular no express or implied warranties regarding the use of the product in dietary supplements, including without limitation the implied warranties of merchantability and fitness for a particular purpose, and Roquette disclaims liability for any loss and/or damage related to such use. Roquette, further, does not warrant that the information or its use will not infringe any patent or other proprietary rights of any third party. Roquette providing this information is not a commitment to sell any product encompassing any of such information in the future.

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