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Calcium sulphate dihydrate – A diluent excipient for multiple pharmaceutical formulations

Calcium sulphate dihydrate is an inorganic salt of calcium and sulfate that naturally occurs as the mineral gypsum. In the pharmaceutical industry, it is primarily used as a diluent excipient in tablet and capsule formulations due to its excellent compressibility, high chemical stability, inert nature, and negligible hygroscopicity.

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    1. General introduction of Calcium Sulphate Dihydrate

    Calcium sulphate dihydrate (gypsum) is one of the most widely mined and utilized sulfate minerals worldwide, with annual global demand reaching hundreds of millions of tonnes. It is obtained from two primary sources: natural gypsum deposits and chemical synthesis. While the vast majority is used in the construction and cement industries, a small proportion of pharmacopeial-grade gypsum is utilized as a pharmaceutical excipient due to its inertness, high chemical stability, and low hygroscopicity.

    2. Active Composition of Calcium Sulphate Dihydrate

    • Material name            : Calcium sulphate dihydrate
    • Empirical formula      : CaSO4.2H2O
    • Appearance                 : A white or off-white crystalline powder or granules, odorless and tasteless
    • Soubility                      : Silightly souble in water, practically insoluble in ethanol (95%)
    • pH                                : 7,3 (10% slurry)
    • Loss of Drying (LoD)  : 19,0 - 23,0%
    • Density bulk                : 0,67 g/cm3
    • Density tapped           : 1,12 g/cm3
    • Density true                : 2,31 g/cm3

    3. Key Advantages of Calcium Sulphate Dihydrate

    • Ideal Chemical Inertness:The simple manufacturing process enables Calcium Sulphate Dihydrate to achieve high purity with low impurity levels. Combined with its chemically inert nature, it exhibits broad compatibility with a wide range of active pharmaceutical ingredients (APIs), minimizing the risk of chemical incompatibilities and contributing to formulation stability.
    • Low Hygroscopicity:Calcium Sulphate Dihydrate is practically non-hygroscopic, making it suitable for formulations containing moisture-sensitive APIs while helping maintain product stability throughout manufacturing and storage.
    • Excellent Processing Performance: Owing to its excellent flowability and compressibility, Calcium Sulphate Dihydrate is well suited for high-speed direct compression as well as dry granulation processes, enabling efficient and robust tablet manufacturing.
    • High Batch-to-Batch Consistency: Its straightforward manufacturing process supports reproducible formulation performance and manufacturing quality.

    4. Applications of Calcium Sulphate Dihydrate

    • Pharmaceutical Applications: Primarily used as a diluent excipient in tablet and capsule formulations, as well as in matrix tablet systems, particularly for intestinal drug release applications.
    • Medical Applications: Used as adental impression and casting material, and as a molding material in reconstructive and cosmetic surgery.
    • Construction Applications: Widely used in the manufacture of cement, plaster, and mortar, as well as in moisture-resistant and thermal insulation materials.
    • Water Treatment Applications: Utilized in water filtration systems and for improving water quality.

    5. Commercial Products using Calcium Sulphate Dihydrate

    6. Product contact Information

    For more information on Calcium carbonate supply, please contact us:

    • Consultation Hotline: +84 (0) 834 560 500
    • Email:: director@biorichgroup.com
    • Website: www.biorichgroup.com
    • Sample / COA Request: Please contact us via email to receive samples and the latest Certificate of Analysis (COA).

     

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