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Stearate
Magnesium

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Pharmaceutical Excipients

Magnesium Stearate

Magnesium Stearate is a versatile pharmaceutical excipient, primarily used as a vital lubricant in the manufacturing of tablets and capsules. It consists of a blend of magnesium salts of fatty acids, principally stearic and palmitic acid. Its key role is to prevent the adhesion of powder to the surfaces of tablet presses and encapsulation equipment, ensuring high manufacturing efficiency and smooth powder flow.

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:
Lubricant, Anti-adherent Agent, Glidant aid.
Chemical Formula:
$Mg(C_{18}H_{35}O_2)_2$ (Magnesium salt of stearic acid).
Mechanism of Action:
Reduces friction between powder particles and the die wall surfaces, preventing tablet sticking and improving powder flowability into the compression die.
Biopharmaceutical Note:
Can potentially impact the dissolution rate of tablets; requires careful control of blending time and concentration during formulation.
Compressed Tablets

Immediate-release, extended-release, and complex compressed tablets.

Ensures non-sticking to punch faces and improves the finished tablet's surface quality and integrity.

Hard Capsules

Powder filling into capsules.

Reduces friction between the powder and filling equipment, enhancing the speed and efficiency of encapsulation.

Dry Blends and Powders

Nutritional supplement powders and direct compression blends.

Provides enhanced flow properties to ensure homogeneity and accurate dose filling.

Regulatory Compliance

The product conforms to the specified requirements of the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and/or British Pharmacopoeia (BP).

Fatty Acid Profile Determination

Precise determination of the ratio of stearic acid to palmitic acid (typically between 40:90 and 60:90) to ensure consistent lubrication performance..

Purity and Impurity Control

Strict control over excipient purity and moisture content to maintain its stability and lubricating efficacy.

Manufacturing Operations

Production is conducted in a rigorous cGMP environment, ensuring consistency in physical properties (e.g., bulk density and surface area).

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