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Sodium Starch
Glycolate

To guarantee the highest purity and efficacy, we adhere to strict global standards

Pharmaceutical Excipients

Sodium Starch Glycolate

Sodium Starch Glycolate (SSG) is a vital, chemically modified pharmaceutical excipient, primarily utilized as a Superdisintegrant in tablet and capsule formulations. Derived from potato or corn starch, it is characterized by its very high water uptake and rapid swelling capacity, ensuring ultra-fast tablet disintegration upon exposure to gastric fluids. SSG is an indispensable component in Immediate Release (IR) formulations that require a rapid onset of action..

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:
Superdisintegrant
Chemical Structure:
Sodium salt of carboxymethyl of starch.
Mechanism of Action:
Rapidly absorbs water and undergoes high-magnitude Swelling within the tablet matrix, generating a high Disruptive Force that breaks the tablet into smaller particles.
Optimal Usage:
Effective at low concentrations (1% to 5%), and often added partially in the internal blending phase and partially in the external blending phase for optimal performance.
Fast-Release Tablets

Immediate Release (IR) tablets and capsules.

Ensures an extremely fast disintegration time (typically less than one minute) to guarantee a quick onset of drug action.

Directly Compressed Tablets

Tablets manufactured without prior granulation.

Maintains its disintegrating effectiveness even under high compression forces.

Fixed-Dose Combinations (FDCs)

Tablets containing multiple active pharmaceutical ingredients (APIs).

Good compatibility with most APIs and other excipients.

Regulatory Compliance

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

Swelling Power Testing

Rigorous testing of its Swelling Capacity and water absorption rate is conducted to ensure fast and consistent disintegration performance.

Purity and Impurity Control

Strict control over residual sodium chloride content and moisture content to ensure the stability of the final product.

Manufacturing Operations

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

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