PEARLITOL®

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.

® Registered trademark(s) of Roquette Frères

Pyrogen Free

DMF/CEP Available

GMP Certificate

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

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PEARLITOL® PF

Key attributes: High purity, consistency, and pyrogen-free

Pyrogen-free mannitol for intracranial application

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Registrations may vary depending on local regulations

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European Pharmacopoeia
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• A CEP and Drug Master File (DMF) are available. Please contact us to discuss this information.

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Mannitol Pyrogen Free Grade

Applications

Functional Properties

Other Properties and Benefits

Documents & Samples

Product Types

PEARLITOL® PF

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Applications

Functional Properties

Other Properties and Benefits

Documents & Samples

Product Types

PEARLITOL® PF

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Regulation & Compliance

Compliance

Regulatory

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