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PEARLITOL®

Low endotoxin Mannitol

Available in 12, 25 and 50kg plastic drums, and Roquette Precision Dispense packaging

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.

Roquette's in-process quality controls ensure a consistent supply of raw materials and excipients to help bring your biologics to life. Through our integrated supply chain and rigorous quality systems, we reduce the risks associated in biopharmaceutical manufacturing.

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

    Applications

    • Downstream
    • Single-use Manufacturing

    Functional Properties

    • Protein Stabilization
    • Precision Dispense

    Other Properties and Benefits

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

    Documents & Samples

    Cosmetics
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    Unfortunately Low endotoxin grade mannitol are not available in $country.

    Product Types

    PEARLITOL® BIOPHARMA - #450003

    Unfortunately this product is not available for sampling
    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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