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PEARLITOL®

Mannitol Pyrogen Free Grade

PEARLITOL® PF, a mannitol pyrogen-free from Roquette, 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 Freres
    Pyrogen Free
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    DMF/CEP Available
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    GMP Certificate
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    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

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    Product Types

    PEARLITOL® PF - #450002

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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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    In accordance with its online legal notice, Roquette may use data you have provided. In accordance with the laws and regulations in force, you have the right to access, rectify, modify and delete personal information that you have communicated to us. By supplying your contact information, you authorize Roquette to contact you (via email, phone and/or mail) about Roquette, its products and services. You have the opportunity to opt out of future communications. To exercise your rights, please fill the form available on Data Protection page. For more information, please write to: DPO@roquette.com or at: Roquette, Corporate Legal Jennifer Godin, Data Protection Officer, rue de la Haute Loge, 62080 Lestrem Cedex France.
    Entering your details below will send your query to the relevant team for a swift and helpful response. We will not use your details for anything other than replying to your query.
    Products Details
    Your Details
    In accordance with its online legal notice, Roquette may use data you have provided. In accordance with the laws and regulations in force, you have the right to access, rectify, modify and delete personal information that you have communicated to us. By supplying your contact information, you authorize Roquette to contact you (via email, phone and/or mail) about Roquette, its products and services. You have the opportunity to opt out of future communications. To exercise your rights, please fill the form available on Data Protection page. For more information, please write to: DPO@roquette.com or at: Roquette, Corporate Legal Jennifer Godin, Data Protection Officer, rue de la Haute Loge, 62080 Lestrem Cedex France.
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