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Sodium
Stearate

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Pharmaceutical Excipients

Sodium Stearate

Sodium Stearate is a versatile pharmaceutical excipient derived from the sodium salt of stearic acid. Unlike Magnesium Stearate (a lubricant), Sodium Stearate is primarily an essential Emulsifying and Gelling Agent. It is characterized by its high solubility in hot water and alcohol, making it a vital component in the preparation of topical pharmaceutical formulations, personal care products, and also serving as a binder and lubricant (to a lesser extent) in tablets.

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:
Gelling Agent, Emulsifier, Binder, Lubricant (minor role).
Chemical Formula:
$C_{18}H_{35}NaO_2$ (Sodium salt of stearic acid).
Mechanism of Action:
In aqueous/alcoholic systems, it forms gel structures and acts as a surfactant to stabilize oil-in-water emulsions.
Topical Application:
It is the primary component used in the preparation of gel sticks and certain water/alcohol-based ointments.
Topical Formulations

Gels, Vaginal Suppositories, Solid Deodorants.

Its high capacity for gel formation in the presence of water and alcohols.

Tablets and Capsules

Compressed tablets and oral capsules.

Serves as a reliable binder and flow enhancer when used in low concentrations.

Cosmetic Industries

Soaps and personal care products requiring setting/thickening.

Characterized by good foaming properties and high emulsion stability.

Regulatory Compliance

The product fully complies with the requirements specified in the National Formulary (NF), the European Pharmacopoeia (Ph. Eur.), and/or other food/supplementary standards (FCC).

pH Control

Precise control over the pH (typically slightly alkaline) is maintained to ensure compatibility with sensitive topical formulations.

Purity and Impurity Control

Strict control over excipient purity and moisture content to ensure stability and functional properties.

Manufacturing Operations

Production is conducted in a rigorous cGMP environment, ensuring consistency in physical properties (e.g., particle size).

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