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PolyStardone® XL

1 of 3 products in this brand
PolyStardone® XL is unsurpassed in its performance and versatility as a super disintegrant in formulations. It enables dissolution of the bio-active components as a prerequisite for achieving the desired and required bioavailability. PolyStardone® has good compressibility and fluidity, which can be applied to wet granulation, dry granulation and direct compression technologyAs a super disintegretant, it will not form gel and can effectively improve the disintegration time.

Chemical Name: Polyvinyl Pyrrolidone Copolymer

CAS Number: 9003-39-8

Functions: Disintegrant

Certifications & Compliance: Chinese Pharmacopeia (ChP), European Pharmacopeia (Ph. Eur.), Japan Pharmacopeia (JP), National Formulary (NF), United States Pharmacopeia (USP)

Synonyms: 1-Vinyl-2-pyrrolidinone polymer, 1-Vinyl-2-pyrrolidone homopolymer, 1-Vinyl-2-pyrrolidone polymer, 1-Vinylpyrrolidin-2-one homopolymer, n-Octyl mercaptan-N-vinylpyrrolidone copolymer, N-Vinyl-2-pyrolidone homopolymer, N-Vinyl-2-pyrrolidinone homopolymer, N-Vinyl-2-pyrrolidone homopolymer, N-Vinyl-2-pyrrolidone polymer, N-Vinylbutyrolactam polymer, N-Vinylpyrrolidinone homopolymer, N-Vinylpyrrolidinone polymer, N-Vinylpyrrolidone homopolymer, N-Vinylpyrrolidone polymer, Poly(1-vinyl-2-pyrrolidinone), Poly(1-vinyl-2-pyrrolidone), Poly(1-vinylpyrrolidinone), Poly(N-vinyl-2-pyrrolidinone), Poly(N-vinyl-2-pyrrolidone), Poly(N-vinyl-γ-butyrolactam), Poly(N-vinylbutyrolactam), Poly(N-vinylpyrrolidinone), Poly(N-vinylpyrrolidone), Poly(vinylpyrrolidinone), Poly(vinylpyrrolidone), Polyvinyl polypyrrolidone, Polyvinylpyrrolidone, Povidone, Vinylpyrrolidinone polymer, Vinylpyrrolidone homopolymer, Vinylpyrrolidone polymer

Technical Data Sheet

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Knowde Enhanced TDS

Identification & Functionality

Pharma & Nutraceuticals Functions
CAS No.
9003-39-8
EC No.
618-363-4
Chemical Structure

Chongqing Star-Tech Specialty Products PolyStardone XL Chemical Structure

Features & Benefits

Features

Physical Properties :
Non-ionic polymer
High porosity and hydration
Easy compression and viscoelastic deformation
No gel formation
Stable in acids and bases

Performance Impact :

No interaction with ionic APIs (i.e. Ranitidine, Cetirizine)
Combines wicking and swelling mechanisms to achieve rapid tablet disintegration at low concentrations(1-5%)
Increased tablet tensile strength and reduced friability due to high compressibility. Especially suitable for poorly compressible APIs
No gel formation even at higher concentrations (10%), idea for ODTs
Suitable for a variety of pH sensitive formulations

Summary

The case study demonstrates the effectiveness of PolyStardone® as a super disintegrant for a tablet matrix containing both water-soluble (lactose) and insoluble (dibasic calcium phosphate), mediumcompactable fillers. The performance of PolyStardone® was compared to other crospovidone products in the market. We believe that: PolyStardone® XL and PolyStardone® XL-10 have similar performance to import competitor A and import B, and are better than domestic competitor C and D in terms of compactibility and disintegration capabilities. In this case, PolyStardone® XL ensures rapid disintegration regardless of compaction force. Furthermore, PolyStardone® XL-10 offers additional benefits in increasing tablet tensile strength without a compromise in its disintegration efficiency.

Applications & Uses

Application

Insoluble in water or common organic solvents, the powder particles are porous microstructures with high specific surface area.

As a super disintegretant, it will not form gel and can effectively improve the disintegration time.

Properties

Physical Form
Appearance
White or yellowish-white powder
Typical Properties
ValueUnitsTest Method / Conditions
NameCrospovidone (PVPP)
Peroxidesmax. 100ppm
Molecular formula(C6H9NO)n
NVP max. 10ppm
CDE register numberF20180000229
Sulfated ash max. 0.1%
Water-solube substances max. 1.5%
Typical D50100-120μm
Loss on drying max. 5.0%
Nitrogen 11.0-12.8%
Typical peroxidemax. 100ppm

Regulatory & Compliance

Technical Details & Test Data

Technical Analysis

Chongqing Star-Tech Specialty Products PolyStardone XL Technical Analysis

Packaging & Availability

Packaging Type
Packaging and Storage

Packed in 20 kg fiber drum or 15 kg plastic drum, inner lined with PE bags

Special packing is available according to customer's requirement

Preserve in tight containers