PEARLITOL® PF pyrogen-free mannitol is used for parenteral preparations and provides excipient and API benefits.
As an excipient, it is an isotonic agent and a bulking agent for freeze-dried powder for injection or infusion.
As an API, it offers various functionalities: osmotic diuretic agent in small and large volume parenteral injectables, diagnostic agent for kidney function, adjunct in the treatment of an acute renal failure, reduction of intracranial pressure in the treatment of cerebral oedema, reduction of intraocular pressure and detoxifier.
Water content (LOD)
Water Content (LOD) Maximum: 0.5 %
Very soluble in water (216 mg/ml of water at 25 °C), practically insoluble in ethanol.
Minimum melting temperature : 166 °C
Maximum melting temperature: 170 °C
Water sorption isotherm at 20°C
Glass Transition Temperature of the Cryo-Concentrated Phase Tg'
® 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.