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Polyplasdone Crospovidone

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MOQ : 1 Piece

Polyplasdone Crospovidone Specification

CAS No
9003-39-8

Physical State
Solid

Shelf Life
5 years

Purity
>99%

Packaging Type
HDPE Drum / Double Polybag

Ph Level
Neutral to slightly alkaline (pH 5-8 in suspension)

Molecular Formula
(C6H9NO)n

Storage Instructions
Store in a cool, dry place, tightly closed

Melting Point
Decomposes before melting

Density
0.4 Gram per cubic centimeter(g/cm3)

Usage
Tablet and capsule disintegrant

Molecular Weight
111.14 g/mol (average)

Size
Custom packaging sizes available

Grade
Pharma Grade

Type
Disintegrant

Application
Pharmaceutical excipient

Appearance
White to off-white, free-flowing powder

Purity(%)
>99%

Functionality
Superdisintegrant for oral solid dosage forms

Odor
Odorless

Compatibility
Compatible with a wide range of APIs

Residual Peroxide
Not more than 400 ppm

Loss on Drying
Not more than 5.0%

Heavy Metals
Not more than 10 ppm

Solubility
Insoluble in water; swells in contact with water

Regulatory Status
USP/NF, EP, JP Compliant

Moisture Content
Typically <5%

Particle Size
95% passes through 100 mesh

Stability
Stable under recommended storage conditions

Microbial Limit
Complies with pharmacopeial standards

Polyplasdone Crospovidone Trade Information

Minimum Order Quantity
1 Piece

Payment Terms
Cash Advance (CA), Cash in Advance (CID)

Supply Ability
3 Pieces Per Week

Main Export Market(s)
Australia, Eastern Europe, Middle East, Central America, South America, Western Europe, Asia, North America, Africa

About Polyplasdone Crospovidone

Polyplasdone Crospovidone

Chemistry: PVP polymers and VP derivatives

Polyplasdone crospovidone superdisintegrants are synthetic, insoluble, but rapidly swellable, crosslinked homopolymers of N-vinyl-2-pyrrolidone. Crospovidone provides rapid disintegration and dissolution to oral solid dosage forms. Polyplasdone crospovidone particles are granular and porous compared with other superdisintegrants. The high surface area combined with unique chemistry results in high interfacial activity that enhances the dissolution of poorly soluble drugs in a way that is not possible with other disintegrant technologies.

The regulatory compliance information for all Ashland products varies by product family and grade. For specific data about the grade you are interested in please refer to our Excipient Information Package and the Certificate of Analysis (COA).

Superior Performance as a Superdisintegrant

Polyplasdone Crospovidone offers exceptional disintegration capabilities in tablets and capsules. Its unique swelling mechanism accelerates tablet breakdown, improving dissolution and bioavailability of active pharmaceutical ingredients. Designed to comply with stringent pharmacopeial standards, it consistently delivers reliable performance across diverse formulations.

Quality and Compliance Assured

Each batch of Polyplasdone Crospovidone undergoes rigorous quality testing, ensuring compliance with USP/NF, EP, and JP standards. It provides high purity (>99%), optimal particle size, and strict control of residual peroxide, heavy metals, and moisture. The excipient is packaged securely to preserve its integrity and shelf life.

Versatility and Compatibility

Built for flexibility, Polyplasdone Crospovidone is compatible with a wide range of APIs, making it suitable for various oral solid dosage forms. It offers ease of use in manufacturing and is provided in custom packaging sizes tailored to customer needs, supporting both small and large scale pharmaceutical production.

FAQ's of Polyplasdone Crospovidone:

Q: How is Polyplasdone Crospovidone used in pharmaceutical formulations?

A: Polyplasdone Crospovidone functions as a superdisintegrant in tablets and capsules. By rapidly swelling upon contact with water, it promotes quick breakdown of the dosage form, ensuring timely release and absorption of the active pharmaceutical ingredient.

Q: What are the key benefits of using Polyplasdone Crospovidone in oral solid dosage forms?

A: The main advantages include accelerated tablet disintegration, enhanced bioavailability of medicines, broad compatibility with APIs, and compliance with international pharmacopeial standards. Its high purity and safety make it a preferred choice for pharmaceutical manufacturers.

Q: When should Polyplasdone Crospovidone be added during the tablet manufacturing process?

A: It can be incorporated during both wet granulation and direct compression processes. Adding it at different stages can optimize disintegration performance, depending on the specific formulation and production method.

Q: Where should Polyplasdone Crospovidone be stored to maintain its quality?

A: To ensure stability and efficacy, store Polyplasdone Crospovidone in a tightly closed container in a cool, dry place. Adhering to these storage conditions preserves its physical and chemical properties.

Q: What is the process for verifying the quality of Polyplasdone Crospovidone?

A: Every batch is tested for compliance with pharmacopeial standards, including purity, heavy metals, residual peroxides, particle size, microbial limits, and moisture content. Documentation is provided to support regulatory requirements and quality assurance.

Q: Is Polyplasdone Crospovidone compatible with all types of active pharmaceutical ingredients?

A: It is compatible with a wide range of APIs due to its inert nature, enhancing versatility in formulation development. However, compatibility studies are recommended for each new formulation to ensure performance and stability.

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