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Crospovidone

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Pharmaceutical Excipients

Crospovidone (PVPP)

Crospovidone (PVPP) is a synthetic pharmaceutical excipient, a water-insoluble, cross-linked polymer of polyvinylpyrrolidone. It is characterized by its very high and rapid water uptake capacity without forming a gel, making it an extremely efficient Superdisintegrant. Crospovidone is a vital component for Immediate Release (IR) formulations requiring rapid disintegration. Furthermore, it is also utilized as a stabilizer and dispersing agent for drugs with low solubility.

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, Solid Dispersion Stabilizer, Dispersing Agent.
Chemical Structure:
Cross-linked polymer of $\text{N-vinyl-2-pyrrolidone}$ (Insoluble).
Mechanism of Action (as Disintegrant):
Rapidly absorbs water via Capillary Action within the tablet pores and swells, generating a high Disruptive Force that breaks the tablet into fine particles. Its key feature is its non-gelling nature.
Mechanism of Action (as Stabilizer):
Prevents the crystal growth of the API in solid solutions, thus maintaining drug solubility.
Standard Grades (Fine)

Wet Granulation, Direct Compression, Capsule Filling.

Fast and effective disintegration at low concentrations (1% - 5%).

Micronized Grades

Solid Dispersions, and formulations requiring a larger surface area.

Improves solubility by dispersing the API at a molecular level.

Other Uses

Used as a dry binder in some formulations and in personal care products.

Enhances flow and compressibility in tablets.

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..

Disintegration Performance

Rigorous testing is conducted on the water uptake rate and disintegration speed to guarantee superior performance.

Purity and Impurity Control

Control over residual monomer content ($\text{N-Vinyl-2-pyrrolidone}$) and moisture, which are critical stability factors.

Manufacturing Operations

Production is conducted in a rigorous cGMP environment, ensuring consistency in physical properties (especially particle size and surface area).

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