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    1. Home
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    3. Super Refined™ Beeswax

    Super Refined™ Beeswax

    Highly purified beeswax used in sustained release oral dosage forms and to increase viscosity of creams and ointments. Modifies melting point of suppository bases.

    Chemical description

    Beeswax

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    • Related resources
    • Material Safety Data Sheets

    Product details

    Pharmacopoeia compliance

    • FDA-IID listed
    • JP/JPE
    • Ph. Eur.
    • USP/NF

    Chemical group

    • Ester
    • Lipid

    Administration route

    • Oral
    • Topical

    Market application

    • Human pharmaceutical

    Functions

    • Stiffening agent

    Physical form

    • White flakes m.p. 60-67ºC

    FREQUENTLY ASKED QUESTIONS

    Explore frequently asked questions about our Super Refined offering

    Drug stability can be compromised by oxidative impurities and reactive species. Our Super Refined™ excipients undergo Croda Pharma's proprietary purification process that reduces these impurities, significantly improving formulation stability and extending shelf life.  

    By employing our proprietary purification technology to reduce aldehydes, peroxides, and other impurities, Super Refined™ excipients greatly reduce the potential for cellular irritation and adverse reactions.

    Super Refined™ excipients are ideal for all administration routes: injectable, ophthalmic, nasal, pulmonary, auricular, oral, topical, transdermal, vaginal and rectal formulations. Super Refined™ are particularly preferred in sensitive therapeutic areas or with unstable active pharmaceutical ingredients (APIs), thanks to our proprietary purification technology ensuring exceptionally low impurity profiles.

    Super Refined™ excipients go far beyond compendial standards. They undergo Croda Pharma’s proprietary purification process to reduce oxidative impurities such as peroxides, aldehydes, and catalyst residues—components that can cause API degradation, instability, and immunogenicity. This makes Super Refined™ excipients ideal for sensitive formulations such as injectables and biologics, where ultra-purity and batch-to-batch consistency are critical.

    Biologic drugs, such as monoclonal antibodies, are highly sensitive to oxidative stress. Even trace levels of impurities like peroxides can cause protein aggregation, loss of potency, or immunogenicity. Super Refined™ excipients help minimise these risks by eliminating those reactive impurities, making them ideal for biological formulations. 

    Injectable formulations bypass many of the body’s natural protective barriers, such as the gastrointestinal tract and first-pass metabolism. As a result, any impurities present are introduced directly into the bloodstream or tissues, where they can cause adverse reactions, inflammation, or toxicity. Using highly purified excipients like those from our Super Refined™ range helps minimise these risks, ensuring better patient safety and enhanced drug stability in parenteral formulations.

    Yes. Many of our Super Refined™ excipients include LAL bacterial endotoxin testing on their Certificates of Analysis (CoAs), supporting their use in parenteral and biologic drug formulations that require tight endotoxin control. 

    Yes. By reducing oxidative impurities that can initiate degradation pathways, Super Refined™ excipients are known to enhance API stability and extend the shelf life of drug formulations. The improved stability provided by Super Refined™ excipients may also support more flexible storage conditions, potentially reducing reliance on cold-chain requirements and enabling ambient temperature storage, depending on the formulation.

    Absolutely. Super Refined™ excipients often comply with multiple pharmacopeias (USP/NF, Ph. Eur., JP, ChP) and are listed in the FDA’s Inactive Ingredient Database (IID). This makes them a strong choice for global regulatory filings.

    Yes. While they are especially valuable in biologics due to their high purity and low impurity profile, Super Refined™ excipients also improve the performance, stability, and sensory attributes of small molecule formulations, including oral and topical products.  

    In addition to superior purity, Super Refined™ excipients come with several added benefits not typically offered with standard grades. These include: 

    • Enhanced Certificates of Analysis (CoAs) with more detailed impurity profiles, including endotoxin testing (LAL) and microbial limits for select products 
    • Nitrogen packaging for improved oxidative stability 
    • Extended pack size options, including single-use packaging 
    • Access to expertise from our technical teams to support custom requests.

    These extras provide peace of mind, accelerate regulatory submissions, and ensure consistent performance from lab-scale to launch.   

    Related resources

    • FDA IID listed products - CP22
      English: 1.3 MB
      FDA IID sheets - all administration routes in single VCN document.
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    • Super Refined™ excipients for oral drug delivery - CP22
      English: 1.8 MB
      Learn more about our Super Refined excipients used for oral drug delivery including SEDDS and SMEDDS.
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    • クローダのSuper Refined™製品シリーズ
      Japanese: 1.1 MB
      剤形の生物学的利用能、薬物送達、および薬効を高める方法をお探しですか？ Crodaの高度に精製された機能的な医薬品添加剤を用いることで、原薬の安定性を最適化し、医薬品製剤の性能を向上することができます...
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    • Super Refined™ excipients for oral drug delivery
      English: 2.1 MB
      Oral drug development of both new and existing chemical entities often face numerous challenges including poor solubility, formulation instability and...
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    • Super Refined™ pharmaceutical excipients - CP22
      English: 744.0 KB
      Super Refined™ pharmaceutical excipients
      Login/Register

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