PEARLITOL® 150 SD
Mannitol-Low Reducing Sugar Content
| Product Name | PEARLITOL® 150 SD |
| 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® 150 SD mannitol is a direct compression excipient with low reducing sugar content (300 ppm max). It is a spray-dried form of mannitol with exceptional physical and chemical stability. 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 | 150 µm |
| Particle Size Distribution by Laser Diffraction |
dv10: 60 µm dv50: 115 µm dv90: 185 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 R9 concave Formula: 98.8% PEARLITOL® 150 SD / 1.2% magnesium stearate Tablet Mass: 400 mg |
| Powder Characteristics |
Powder Flowability (according to Ph.Eur. 2.9.16, 10mm outflow opening): 6 s Bulk Density: 0.46 g/cm3 Tapped Density: 0.55 g/cm3 True Density: 1.514 g/cm3 Specific surface area: 1.3 m2/g |
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.