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Disodium phosphate monohydrate USP PARENTEX PLUS – pH buffering excipient for sterile formulations

Disodium phosphate monohydrate USP PARENTEX PLUS is a USP-grade pH buffering excipient designed for sterile, parenteral, and pH-sensitive pharmaceutical formulations. High-purity material with stringent endotoxin control for advanced pharmaceutical manufacturing.

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    1. General introduction to Disodium phosphate monohydrate USP PARENTEX PLUS 

    Disodium phosphate monohydrate USP PARENTEX PLUS is a high-purity pharmaceutical-grade phosphate excipient widely used in injectable formulations, infusion solutions and pH-sensitive pharmaceutical products. As a phosphate buffering agent, it helps maintain formulation pH stability, minimize active ingredient degradation, and optimize the chemical stability of finished products throughout shelf life.

    PARENTEX PLUS is specifically developed for injectable and sterile pharmaceutical applications, meeting stringent requirements for purity, endotoxin control, and batch-to-batch consistency. In modern pharmaceutical manufacturing, Disodium phosphate monohydrate USP PARENTEX PLUS is recognized as an optimal solution for formulations requiring precise pH control, long-term stability, high compatibility with pH-sensitive active ingredients, and internationally compliant technical documentation.

    2. Active ingredient profile of Disodium phosphate monohydrate USP PARENTEX PLUS

    • Active ingredient name: Disodium phosphate monohydrate
    • Chemical name: Disodium hydrogen phosphate monohydrate
    • Functional class: Phosphate buffering excipient
    • Molecular formula: Na2HPO4·H2O
    • Molecular weight: 159.98 g/mol
    • Appearance: White crystalline powder
    • Solubility: Freely soluble in water
    • Solution pH: Slightly alkaline
    • Quality standard: USP
    • Product grade: PARENTEX PLUS for injectable and sterile pharmaceutical applications

    3. Advantages of Disodium phosphate monohydrate USP PARENTEX PLUS 

    • Stable pH buffering performance: Helps maintain the optimal pH range for sensitive active ingredients and minimizes degradation caused by pH fluctuations.
    • High purity for sterile formulations: Suitable for injectable and infusion applications requiring stringent control of endotoxins and impurities.
    • Excellent compatibility with pharmaceutical active ingredients: Supports the stabilization of pH-sensitive and oxidation-sensitive APIs in advanced formulation systems.
    • Excellent water solubility: Facilitates efficient processing, industrial-scale manufacturing, and improved formulation homogeneity.
    • High chemical stability: Maintains reliable buffering performance under standard manufacturing and storage conditions.
    • Compliance with international pharmacopeial standards: USP-grade material suitable for formulations targeting highly regulated pharmaceutical markets.

    4. Applications of Disodium phosphate monohydrate USP PARENTEX PLUS

    • Sterile injectable solutions:  Used as a phosphate buffer system to maintain stable pH for sensitive active ingredients in injectable formulations.
    • Intravenous infusion solutions: Supports pH control and enhances chemical stability in infusion preparations.
    • Ophthalmic solutions: Used in phosphate buffer systems to maintain physiological pH and improve ocular compatibility.
    • Biological and protein formulations: Helps stabilize the pH environment for biologically sensitive active ingredients.
    • Lyophilized formulations: Supports active ingredient stability during lyophilization and reconstitution processes.
    • Injectable vitamin solutions: Helps stabilize pH and minimize degradation of oxidation-sensitive ingredients in injectable systems.

    5. Commercial products using Disodium phosphate monohydrate

                 

    6. Product contact information

    For further information regarding Disodium phosphate monohydrate 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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