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KLEPTOSE®

Low endotoxin hydroxypropyl beta-cyclodextrin

Available in 10, 25 and 50kg plastic drums, and Roquette Precision Dispense packaging

KLEPTOSE® HP and HPB BioPharma Low endotoxin hydroxypropyl beta-cyclodextrin is a multifunctional excipient that provides protein stabilization in biopharmaceutical downstream applications. These are cyclic oligosaccharides with a bucket-like structure. With a hydrophobic internal cavity and hydrophilic exterior, these starch derivatives can encapsulate molecules, forming inclusion complexes where lipophilic compounds are non-covalently bound within the cavity.

Their unique function to encapsulate and shield water insoluble materials can be utilized to shield exposed hydrophobic residues on aggregation-prone proteins, thereby modulating protein aggregation. Widely used in the formulation of small molecules, highly soluble beta-cyclodextrin derivatives like our KLEPTOSE® HP BioPharma and KLEPTOSE® HPB BioPharma show promise as a multifunctional excipient suitable for biopharma applications.

Representing a promising class of excipients that can reduce protein aggregation induced by physical stress, cyclodextrins can serve as an alternative option to currently used excipients, or a tool to synergistically complement your biotherapeutic formulations.

These materials are suitable for use in biopharmaceutical manufacturing and as an excipient for injectable dosage forms. Contact us today at Roquette to talk to us about these multicompendial materials - EP, USP and JP.
® Registered trademark(s) of Roquette Freres
    Innovative new 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
    • Freely soluble in propylene glycol
    • White or almost white powder
    • Amorphous or crystalline powder

    Documents & Samples

    Cosmetics
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    Product Types

    KLEPTOSE® HP BIOPHARMA - #346105

    Key attributes: Very high purity, Low endotoxin, For application in BioPharma
    Unfortunately this product is not available for sampling
    Higher level of molecular substitution (MS) = 0.90
     

    KLEPTOSE® HPB BIOPHARMA - #346113

    Key attributes: Very high purity, Low endotoxin, For application in BioPharma
    Unfortunately this product is not available for sampling
    Lower level of molecular substitution (MS) = 0.62
     

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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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