PEARLITOL® PF
Pyrogen-Free Mannitol
Product Profile

PEARLITOL® PF
Pyrogen-Free Mannitol

 

Product Name PEARLITOL® PF
Generic Name Mannitol Pyrogen Free Grade
Physico-chemical properties
Compliance EP/USP-NF/JP/IP
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® 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 %

Solubility Very soluble in water (216 mg/ml of water at 25 °C), practically insoluble in ethanol.
Melting temperature

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' -29.3 °C
Osmolality

 

Disclaimer

These typical values are provided for information only and we believe them to be reliable. Methods available upon request.

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