Mannitol Pyrogen Free Grade
"PEARLITOL® PF Mannitol pyrogen-free grade is used for parenteral preparations and Rx injectables. As an API it serves as an osmotic diuretic agent in small and large volume parenteral injectables. As an excipient it is used for Rx injectables as an isotonic agent and a bulking agent for freeze dried powder for injection or infusion.
Mannitol pyrogen-free is also used to reduce elevated pressure in the brain (cerebral oedema) and in the eyes. In these critical solutions, mannitol acts as a pharmaceutical active ingredient and its production has to comply with the internationally accepted GMP standards.
Due to its physical and chemical properties mannitol is the choice excipient for freeze-dried powder for injection or infusion. "
Applications
-
Injectables
- Large Volume Parenteral
- Rx Injectables
Functional Properties
-
Excipient
- Bulking Agent
- Isotonic Agent
-
API
- Osmotic Diuretic Agent
Other Properties and Benefits
- White crystalline powder
Documents & Samples

Product Types
PEARLITOL® PF - #450002
Pyrogen-free mannitol for intracranial application
Order
Regulation & Compliance
Compliance
- European Pharmacopoeia
- United States Pharmacopeia
- Japanese Pharmacopoeia
- Indian Pharmacopoeia
- (Varies by grade)
Regulatory
• A CEP and Drug Master File (DMF) are available. Please contact us to discuss this information.
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