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Sodium
Benzoate

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Pharmaceutical Excipients

Sodium Benzoate

Sodium Benzoate is the Sodium Salt of Benzoic Acid, and it is a widely used preservative in pharmaceutical, food, and cosmetic formulations. It is characterized by its high efficacy in inhibiting the growth of molds, yeasts, and some bacteria, thereby ensuring the Microbiological Stability of acidic and liquid products. Sodium Benzoate is preferred over Benzoic Acid due to its high water solubility, making it easy to incorporate into aqueous solutions. It works optimally in acidic (Low pH) environments, particularly in oral solutions and beverage formulations.

The product conforms to the specified requirements of the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and/or British Pharmacopoeia (BP).
A detailed CoA is issued with every batch, outlining potency, purity profile, and microbiological testing verification.
A comprehensive Drug Master File is available to support registration submissions to regulatory authorities worldwide.
Production takes place in certified facilities that strictly adhere to current Good Manufacturing Practices (cGMP).
Functional Class:
Preservative, Disintegrant (in some applications)..
Chemical Structure:
Sodium salt of $\text{Benzoic Acid}$ ($\text{C}_7\text{H}_5\text{NaO}_2$)..
Mechanism of Action:
As an Inhibitor : The free, unionized Benzoic Acid ions are released, which penetrate the cell wall of microorganisms and halt their growth and reproduction by inhibiting vital enzymes.
Optimal pH Range : Works most effectively in a pH range of 2.5 to 4.5. Efficacy decreases significantly above pH 5.
Solubility:
Readily Soluble in water.
Oral Solutions

Syrups, liquid medicines, and oral rinses.

Provides effective protection for acidic products (e.g., vitamin syrups or acidic-tasting drugs).

Topical Preparations

Acidic creams and ointments.

Ensures the microbiological stability of water-based topical products.

Tablet Preparation

Occasionally used as a secondary Disintegrant..

Aids in the breakdown of the tablet upon contact with water, though this use is secondary..

Flavored Formulations

Flavor enhancement (at low concentrations).

Can impart a slight, acidic note when used in solution.

Regulatory Compliance

The product fully complies with the requirements specified in the United States Pharmacopeia (USP), the European Pharmacopoeia (EP), and/or food standards (FCC).

Purity and Impurity Control

Strict control over Sodium Benzoate purity, minimizing insoluble matter and chlorides.

Efficacy and Stability

Precise determination of the Benzoic Acid equivalent ratio to ensure the required efficacy within the specified pH range.

Manufacturing Operations

Production is conducted in a rigorous cGMP environment, ensuring consistency in physicochemical properties.

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