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Disodium Edetate – A widely used chelating excipient in pharmaceutical and cosmetic formulations

Disodium Edetate is a chelating excipient extensively applied in pharmaceuticals and cosmetics to stabilize formulations, control metal ions, and enhance product shelf-life. The raw material meets international pharmacopeial standards as well as endotoxin and microbiological requirements, making it suitable for a wide range of dosage forms.

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    1. General introduction to Disodium Edetate 

    Disodium Edetate is a sodium salt of ethylenediaminetetraacetic acid (EDTA), a chelating excipient capable of binding to metal ions, widely used in the pharmaceutical and cosmetic industries to indirectly inhibit oxidation processes. Owing to its ability to form stable chelate complexes with divalent and trivalent metal ions, it reduces metal-catalyzed oxidation (e.g., catalyzed by Fe³⁺, Cu²⁺), thereby extending shelf-life and maintaining finished product quality.

    In advanced pharmaceutical and cosmetic formulations, Disodium Edetate is recognized as an essential excipient for optimizing chemical stability, enhancing preservation efficiency, and increasing compatibility in modern delivery systems.

    2. Material information – Disodium Edetate

    • Material Name: Disodium Edetate (or Disodium Edetate Hydrate)
    • Chemical Formula:C10H14N2O8Na2·2H2O
    • CAS Number: 6381-92-6
    • Molecular Weight: 372.24 g/mol
    • Category:Pharmaceutical Excipient
    • Physical Form:White crystalline powder, odorless, slightly acidic taste
    • Solubility: Soluble in water, sparingly soluble in ethanol (95%), practically insoluble in chloroform and ether
    • pH: Approximately 4.3 – 4.7 (1% w/v aqueous solution)
    • Stability: Hygroscopic in solid state; must be stored in tightly sealed containers
    • Quality Standards: USP/NF, EP, BP, JP

    The binding strength and stability of Disodium Edetate complexes with metal ions such as calcium, magnesium, iron, and copper depend significantly on pH and the specific target ion.

    The raw material is strictly controlled for microbial limits and bacterial endotoxins to meet the requirements for sterile preparations.

    3. Key advantages of Disodium Edetate 

    • Strong Chelating Capacity: Forms stable complexes with metal ions such as Fe³⁺, Cu²⁺, Ca²⁺ và Mg²⁺, preventing metal-catalyzed oxidation reactions.
    • Enhanced Formulation Stability: Protects oxidation-sensitive active ingredients and reduces active degradation.
    • Optimized Preservation System Efficiency: Synergistically boosts the performance of antioxidants in pharmaceutical and cosmetic formulations.
    • High Chemical Stability: Heat-stable, retaining integrity even during thermal sterilization processes.
    • Compliance with International Pharmacopeias: Meets USP/NF, EP, BP, and JP standards, suitable for formulations with stringent quality requirements.

    4. Applications of Disodium Edetate

    In pharmaceuticals:

    • Injectable Solutions:Controls trace metal ions and improves stability for oxidation-sensitive active pharmaceutical ingredients (APIs).
    • Ophthalmic Drops: Stabilizes formulations and enhances preservative efficacy in sterile preparations.
    • Oral Liquids: Prevents color degradation and maintains finished product stability over time.
    • Topical Creams & Gels: Stabilizes emulsion systems and protects APIs against metal-induced oxidation.

    In cosmetics:

    • Facial Serums: Stabilizes functional ingredients and maintains formulation quality throughout shelf-life.
    • Moisturizing Creams:Enhances preservative system efficacy and stabilizes emulsion bases.
    • Hair Care Products: Stabilizes formulations and improves the performance of active functional ingredients.

    In food & beverage:

    • Functional beverages: Helps stabilize color and minimize oxidation during storage.
    • Processed food products: Controls metal ions to maintain sensory quality and product stability.

    5. Commercial products using Disodium Edetate

    6. Product contact information

    For further information regarding Disodium Edetate supply capability, technical specifications, or commercial inquiries, please contact us:

    • Hotline: +84 (0) 834 560 500
    •  Email: director@biorichgroup.com
    •  Website: Biorich Group
    • Sample & COA Request: Please contact us via email to request product samples and the latest Certificate of Analysis (COA).
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