Video
Looking for product documentation? Want to order a sample?
Your product sample is added to basket
PEARLITOL®

Low endotoxin grade mannitol

PEARLITOL® BioPharma provides protein stabilization in your biopharmaceutical downstream applications.  Mannitol is used as an excipient in over 50 commercial mAbs, therapeutic proteins and vaccines.

To support innovators and visionaries like you, Roquette's in-process quality controls ensure a consistent supply of raw materials and excipients to help bring your biologics to life. Roquette provides confidence and reduces risk in biopharmaceutical manufacturing through our integrated supply chain and rigorous quality systems.

PEARLITOL® BioPharma is suitable for use in biopharmaceutical manufacturing and as an excipient for injectable dosage forms. Contact us today to talk about our multicompendial materials - EP, JP, USP.
® Registered trademark(s) of Roquette Freres
    Solution for protein stabilization
    Multi-compendial
    Sole custody of the supply chain

    Applications

    • Downstream

    Functional Properties

    • Protein stabilization

    Other Properties and Benefits

    • Freely soluble in water
    • Very slightly soluble in ethanol
    • White or almost white, crystalline powder

    Documents & Samples

    Select an area
    To better serve you and give you exactly the information you need, select an area so we can verify that the product is available for sale there.
    ?
    When a product is verified 'available for sale' in an area, you can be assured that Roquette has met all the standards and registrations required by that area's regulatory authorities.
    Usage Area Selected
    Please select the usage area to continue
    Product not available for sale
    Unfortunately Low endotoxin grade mannitol are not available in $country.

    Product Types

    PEARLITOL® BIOPHARMA - #450003

    Attribute Regulation
    cGMP ICH-Q7 or IPEC PQG GMP*
    Supply Chain Integrity / Transparency IPEC Good Distribution Practices Guide for Pharmaceutical Excipients.
    Aflatoxins (EC) No 1881/2006
    Allergens (EC) No 1169/2011
    Conflict minerals Section 1502 of the U.S. Dodd-Frank Act**
    Dioxin (EC) No 1881/2006, (EU) No 1259/2011
    Elemental Impurities ICHQ3D
    Genotoxic Impurities ICHM7***
    GMO (EC) No 1829/2003, (EC) No 1830/2003
    Metal Catalysts EMEA/CHMP/SWP/4446/2000
    Nanoparticles (EC) No 1169/2011**
    Pesticides (EC) No 396/2005
    Residual Solvents ICHQ3C***
    Attribute Other Requirements
    Animal Origin No TSE/BSE**
    Ethylene Oxide **
    Ionizing Radiation **
    Latex ****
    Melamine ***
    Viral Safety **

    *Depending on the product
    **Not used in the manufacturing process
    ***Neither used nor generated in the manufacturing process
    ***Not generated in the manufacturing process

    Order

    {{datas.data.name}} {{datas.data.brandOriginal}}

    Key attributes:
    • {{attribute}}
    Quantity
    Size
    Total
    {{package.formattedSize}}
    {{package.formattedTotal}}
    You may order up to 3 samples per product.
    This comment must be less than 250 chars
    Form errors
    • {{error}}
    Server Error.
    We are unable to carry out a sample order right now.
    Please try again later or alternatively you can contact us.
    Server Error.
    Order now

    Regulation & Compliance

    Registrations may vary depending on local regulations

    Compliance

    • European Pharmacopoeia
    • United States Pharmacopeia
    • Japanese Pharmacopoeia

    Regulatory

    • Manufacture: ICH-Q7 or IPEC PQG GMP - Production and packaging
    • Distribution: IPEC Good Distribution Practices
    • Registrations vary depending on local regulations.

    Need more support ?

    Help & Support

    If you need help, please get in touch with our technical team.
    Appointment
    If you feel your project needs a more in-depth discussion, please request an appointment
    The information available here is not intended to indicate that a specific product is available or approved for sale in a country. It is meant to provide general information about our products and facilities. Should you have any specific questions about the availability of a product in particular, please click here.
    • {{productType.nameProductType}} - {{productType.idProductType}}
      • {{ document.disclaimer }}
    Server Error.
    We are unable to carry out a download document right now.
    Please try again later or alternatively you can contact us.
    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
    Please choose "Not applicable" if your country is neither USA nor Mexico
    none
    * Required fields
    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.
    Help Details
    Your Details
    Please choose "Not applicable" if your country is neither USA nor Mexico
    none
    * Required fields
    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
    Please choose "Not applicable" if your country is neither USA nor Mexico
    none
    * Required fields
    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
    Please choose "Not applicable" if your country is neither USA nor Mexico
    none
    * Required fields
    Our site uses cookies for web statistics usage and to enhance your user experience. For more information visit our cookie policy and learn how to customize cookies setting.
    Click Agree to accept cookies and go directly to the site.