PEARLITOL® 200 SD
Mannitol
Product Profile

PEARLITOL® 200 SD
Mannitol

EP/USP/JP/CHP compliance

 

Product Name

PEARLITOL® 200 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® 200 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: 0.5 %

Morphology

Average Mean Particle Diameter

150 µm

Particle Size Distribution by Laser Diffraction

dv10 = 65 µm
dv50 = 150 µm
dv90 = 240 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  40 tablets/min (linear punch velocity: 152 mm/s; simulated rotary press speed: 250000 tablets/hour) 
Tooling 

10 mm Flat
10 mm R9 Concave 

Lubrication  1.2% Magnesium stearate 
Tablet Mass  400 mg 

Powder Characteristics

Powder Flowability: 5.6  s (according to Ph.Eur. 2.9.16, 10mm outflow opening)
Bulk Density: 0.48 g/cm3
Tapped Density: 0.57 g/cm3
True Density: 1.514 g/cm3
Specific Surface Area: 1.2 m²/g
Angle of Repose: 40 °

Trial quantities are now available to order online* for small scale lab and pilot production.

*Shipping to USA addresses only   Order a trial quantity

 

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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