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Dextrose Anhydrous BioPharma

Dextrose Anhydrous BioPharma from Roquette is used upstream in the cell culture process as an energy and carbon source during the production of therapeutic proteins.
To support innovators and visionaries like you, our 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.   
Dextrose Anhydrous BioPharma is a multi-compendial material - USP, EP, JP. We are ready to help you with your upstream application needs for cell culture ingredients. Contact us today to talk about your BioPharma needs.
® Registered trademark(s) of Roquette Freres
    Cell culture media ingredient
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    Multi-compendial
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    Sole custody of the supply chain
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    Applications

    • Upstream

    Functional Properties

    • Cell culture ingredients

    Other Properties and Benefits

    • White or almost white, crystalline powder

    Documents & Samples

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    Product Types

    DEXTROSE ANHYDROUS BIOPHARMA - #361417

    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

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    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.

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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: [email protected] 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
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    Please choose "Not applicable" if your country is neither USA nor Mexico
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    * Required fields
    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: [email protected] or at: Roquette, Corporate Legal Jennifer Godin, Data Protection Officer, rue de la Haute Loge, 62080 Lestrem Cedex France.
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