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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

    Documents & Samples

    Cosmetics
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    Product Types

    PEARLITOL® PF - #450002

    Key attributes: High purity, consistency, and pyrogen-free
    Unfortunately this product is not available for sampling

    Pyrogen-free mannitol for intracranial application 

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    Regulation & Compliance

    Registrations may vary depending on local regulations

    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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