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Pregelatinized
Starch

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

Pharmaceutical Excipients

Pregelatinized Starch

Pregelatinized Starch (PGS) is a Multifunctional Pharmaceutical Excipient typically derived from corn or potato starch, which has been partially processed physically and chemically. This excipient offers simultaneous functional properties: it serves as a Binder, a Disintegrant, and a Filler (Diluent). PGS is ideal for formulations utilizing Direct Compression or Wet Granulation processes, simplifying the formulation complexity and reducing the number of excipients required.

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:
Binder, Disintegrant, Diluent (Filler).
Chemical Structure:
Partially modified starch, readily soluble in cold water.
Mechanism of Action:
As a Binder : Provides good cohesiveness due to the adhesive properties of the partially gelatinized starch particles.
As a Disintegrant : Absorbs water and swells, leading to the rapid breakup of the tablet.
Optimal Use:
Significantly improves the flow properties and compressibility of the powder mix, making it ideal for the Direct Compression manufacturing process.
Direct Compression Tablets

Capsules and Dry Blends

Significantly enhances tablet compressibility without negatively impacting disintegration time.

Wet Granulation

Used as both a binder and a disintegrant.

Reduces the need for multiple excipients, aiding the formation of robust granules and supporting faster drying rates..

Capsules and Dry Blends

Capsule filling and nutritional supplements.

Acts as a flow enhancer and a biologically inert diluent.

Regulatory Compliance

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

Viscosity and Degree of Gelatinization

Strict control over solution viscosity and the degree of gelatinization is maintained to ensure consistent performance as both a binder and a disintegrant.

Purity and Impurity Control

Control over moisture content and residual solvents.

Manufacturing Operations

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

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