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Zhiyuan has more than 70 varieties of cyclodextrin raw materials,
including cyclodextrin derivatives, cyclodextrin inclusion complexes,
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Hydroxypropyl Beta Cyclodextrin CAS 128446-35-5 Injection Grade



Hydroxypropyl beta-cyclodextrin is a chemical compound that belongs to the derivatives of cyclodextrin. It is composed of cyclic six-sugar molecules, and the hydroxypropyl substituent allows it to have good solubility and stability in solution. And it has the characteristics of ultra-low beta Cyclodextrin residue, which is suitable for solubilization and solubilization of injection drugs

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    Name Hydroxypropyl beta Cyclodextrin
    CAS No. 128446-35-5
    Molecular Formula C42H70-nO35(C3H7O)n
    Molecular Weight 1134.98+58n
    Appearance white powder, insipid, innocent
    Assay ≥98%
    Classification Injection Grade
    Quality standard USP/CP/EP Standard
    DMF No. 030168

    Molecular structuer:

     

    Hydroxypropyl beta Cyclodextrin (HP-β-CD)is a hydroxyalkylated derivative of beta Cyclodextrin(β-CD). Hydroxypropyl β cyclodextrin is non-toxic and has no side effects.

    Hydroxypropyl beta-cyclodextrin (HPβCD) finds applications in various fields, such as:

    1.Pharmaceutical Field: HPβCD is commonly used in drug delivery systems to enhance the solubility, stability, and bioavailability of drugs. It forms inclusion complexes with drugs, leading to controlled drug release and prolonged drug efficacy. Additionally, it can improve the taste of drugs and mask their bitterness.

    2.Food Industry: HPβCD serves as a food additive, providing enhanced flavor, texture, and stability. It is used to stabilize flavors, control the release of volatile compounds, and improve the taste and storage performance of food products.

    3.Cosmetics Industry: HPβCD finds wide application in cosmetics to enhance the stability and penetration of active ingredients, improving the texture and efficacy of products. It is used in skincare products, makeup products, oral care products, and more.

    4.Medical Device Field: HPβCD is also used in lubricants and protectants for medical devices. It improves the sliding performance of devices, reduces friction and wear, and enhances user experience and device lifespan.

    Features:

    1.Solubility: Hydroxypropyl cyclodextrin exhibits good water solubility, quickly dissolving in water to form a transparent or slightly yellowish solution.

    2.Stability: Compared to regular cyclodextrin, hydroxypropyl cyclodextrin demonstrates higher stability under acidic and alkaline conditions, maintaining its properties and functionality.

    3.Inclusion complex formation: With its molecular structure featuring a cyclic cavity, hydroxypropyl cyclodextrin can form inclusion complexes with various substances such as drugs, flavors, and cosmetic ingredients. This enhances their stability, water solubility, and bioavailability.

    4.Mildness: Hydroxypropyl cyclodextrin exhibits good compatibility with most drugs and compounds, causing no significant adverse reactions or interactions.

    5.Biocompatibility: Within a certain concentration range, hydroxypropyl cyclodextrin demonstrates good biocompatibility with humans and animals, causing no significant toxic side effects.

    6.Solubility enhancement: Hydroxypropyl cyclodextrin can enhance the water solubility of hydrophobic drugs and compounds, thereby improving their dissolution rate and bioavailability.

    Factory information and advantages

    Hydroxypropyl beta Cyclodextrin manufacturer-Shandong Binzhou Zhiyuan Biotechnology Co., Ltd which has completed registration with FDA, and the registration information is as follows:

    Company name: Shandong Binzhou Zhiyuan Biotechnology Co., Ltd

    FDA ESTABLISHMENT IDENTIFIER (FEI No.):3011680310

    ESTABLISHMENT ADDRESS: Boxing Economic Development Zone,, Binzhou, Shandong 256500, China (CHN)

    DUNS: 548171477

    And we have a domestically advanced GMP standard clean production workshop for pharmaceutical excipients, a large pharmaceutical storage warehouse, a complete R&D and quality inspection center and a professional scientific research team.

    Notice:

    When using hydroxypropyl beta-cyclodextrin (HPβCD), it’s important to keep the following considerations in mind:

    1.Use the appropriate concentration: Choose the appropriate concentration of HPβCD based on the specific application requirements. Different products and formulations may require different concentrations, so carefully read the product instructions or consult professionals for proper guidance.

    2.Comply with regulations and safety requirements: Ensure compliance with applicable regulations and safety requirements when using HPβCD. This includes checking and adhering to regulatory requirements for pharmaceuticals, food, cosmetics, or other relevant products to ensure compliance and safety.

    3.Be aware of allergic reactions: Some individuals may be allergic or sensitive to HPβCD. Conduct a skin sensitivity test before using HPβCD and closely observe for any allergic reactions. If any discomfort or allergic symptoms occur, discontinue use immediately and consult a doctor.

    4.Storage and stability: When storing HPβCD, follow the manufacturer’s recommendations. Typically, it is advised to store it in a dry, cool place, away from sunlight and heat sources. Ensure proper sealing of the container to maintain its stability and quality.

    5.Compatibility: Consider the compatibility of HPβCD with other ingredients when formulating complex formulations. Some substances may affect the performance or stability of HPβCD, so thorough compatibility testing should be conducted during formulation design.

    6.Understand product characteristics: It’s essential to have a good understanding of the characteristics, properties, and scope of application of HPβCD. Detailed information on HPβCD’s solubility, stability, complexation ability, and release properties can help optimize its use in specific products or formulations.

    Test Standard USP-NF2023
    ITEMS CRITERIA
    Appearance White or almost white, amorphous or crystalline powder. Freely soluble in water and in propylene glycol.
    Molar substitution 0.40~1.50
    Betadex ≤1.5%
    Propylene glycol ≤2.5%
    Any other single impurity ≤0.25%
    Total impurities excluding betadex and propylene glycol ≤1.0%
    Propylene oxide ≤0.0001%
    Loss on drying ≤10.0%
    Clarity of solution 1.0g/2ml water solution is clear and transparent
    Conductivity ≤200μS/cm
    Bacterial Endotoxins Test ≤10EU/g
    The total aerobic microbial count ≤1000cfu/g
    The total combined molds and yeasts count ≤100 cfu/g

    Hydroxypropyl Betadex has several applications, primarily in the pharmaceutical industry, due to its ability to enhance the solubility, stability, and bioavailability of poorly soluble drugs. Some of its key applications include:

    1. Drug Solubilization: Hydroxypropyl Betadex forms inclusion complexes with poorly soluble drugs, improving their solubility in aqueous solutions. This enables the formulation of drugs that would otherwise be difficult to administer orally or through other routes.

    2. Enhanced Drug Delivery: By increasing the solubility of drugs, Hydroxypropyl Betadex can improve their absorption in the body, leading to enhanced drug delivery and therapeutic efficacy. This is particularly useful for drugs with low bioavailability.

    3. Stabilization of Drugs: Hydroxypropyl Betadex can stabilize drugs by protecting them from degradation, such as hydrolysis or oxidation, thus extending their shelf life and maintaining their efficacy over time.

    4. Masking of Unpleasant Taste or Odor: In oral formulations, Hydroxypropyl Betadex can mask the unpleasant taste or odor of certain drugs, improving patient acceptability and compliance with medication regimens.

    5. Ocular Drug Delivery: Hydroxypropyl Betadex is used in ophthalmic formulations to solubilize drugs for the treatment of eye conditions. Its ability to enhance drug solubility makes it valuable for delivering drugs through the ocular route.

    6. Inclusion in Formulation Development: Pharmaceutical researchers and formulators use Hydroxypropyl Betadex as an excipient in the development of new drug formulations to overcome solubility challenges and improve drug delivery profiles.

    Overall, Hydroxypropyl Betadex plays a critical role in pharmaceutical formulation development, enabling the delivery of poorly soluble drugs and enhancing their therapeutic effectiveness.

    ● Internal packing: inner packaging : PE bag, then put into aluminum foil bag.

    ● Storage: Preserve well-closed containers, protect from moisture.

    ● Label: accordingto customers’ request.

    ● Outer packing: packed in drum.

    ● Packing: 100g/bag,500g/bag, 1kg/bag, 2kg/bag, 10kg/bag/drum, 20kg/bag/drum

    1.Stock:Goods in stock

    2.Delivery:Delivery goods within 1-3 workdays.

    3.Loading location:factory of Binzhou Zhiyuan(China)

    4.Shipping:FOB, CIF, CFR, DDU…..

     

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