JIAOZUO ZHONGWEI SPECIAL PRODUCTS PHARMACEUTICAL CO.,LTD
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Copolymer of Vinylpyrrolidone and Vinylacetate (VP/VA Copolymer), also known as Copovidone, is a versatile binder used in tablets and granules. It demonstrates excellent film-forming properties, adhesion, and surface activity.
It is used as a dry binder for direct compression in pharmaceuticals, and as a binder for wet granulation in tablets, capsules, and granules. Its good plasticity and low glass transition temperature make it suitable for hot melt extrusion to prepare solid dispersions, enhancing drug solubility and bioavailability.
It is also an excellent moisture-sensitive binder for sensitive formulations.
Structure formula：
Appearance: White or yellowish-white powder
CDE register number: F20240000242
Application: Binder for oral preparation by wet granulation, dry granulation and direct compression;
Film-forming for film coating; Solubilizer for solid dispersion.
PVP VA64 | |
pH value | 3.0-7.0 |
K Value | 25.2-30.8 |
Aldehydes(ppm) | ≤500 |
Peroxides(ppm) | ≤400 |
Hydrazine(ppm) | ≤1 |
Monomers(Residue VP+Residue VA) (%) | 0.001 |
Impurity A(2-Pyrrolidone) (%) | ≤0.5 |
Loss on Drying (%) | ≤5.0 |
Sulphated Ash(%) | ≤0.1 |
Heavy Metals(ppm) | ≤20 |
VA content (%) | 35.3-42 max. |
Nitrogen (%) | 7.0-8.0 |
All products comply with Ph. Eur, USP/NF, JP,BP certificate of analysis.
The pH value ranges from 3.0 to 7.0. The K Value is between 25.2 and 30.8. Aldehydes content is measured at less than 500 parts per million (ppm). The level of peroxides is kept below 400 ppm.
The hydrazine content is at or below 1 ppm. The percentage of monomers, which include residue VP and residue VA, is 0.001%.
Impurity A, specifically 2-Pyrrolidone, should be no more than 0.5%. The loss on drying is specified to be less than or equal to 5.0%.
The sulphated ash content must be less than or equal to 0.1%. Heavy metals content is restricted to a maximum of 20 ppm. The VA content is between 35.3% and 42%, with the maximum being 35.3-42%.
Lastly, the nitrogen content varies from 7.0 to 8.0%.
Our products are carefully packaged to ensure safety and maintain quality during transit and storage. They are typically packed in robust 25 kg plastic drums or fiber drums, each lined with protective PE (polyethylene) bags to prevent moisture absorption and contamination. We understand that different customers may have unique packaging needs, and we are happy to accommodate special requests to meet those requirements.
For storage, it is important to keep the products in tight containers to maintain their integrity. This helps to prevent exposure to air and moisture, which could affect the product's performance. We recommend storing the drums in a cool, dry place away from direct sunlight and extreme temperatures. Proper storage conditions will help ensure that the product remains effective and consistent over time.
Additionally, clear labeling is provided on each package to include important information such as batch number, expiration date, and handling instructions. This ensures that users can easily identify and manage their inventory effectively. We are committed to providing not only high-quality products but also reliable and convenient packaging and storage solutions to meet our customers' needs.
Copolymer of Vinylpyrrolidone and Vinylacetate (VP/VA Copolymer), also known as Copovidone, is a versatile binder used in tablets and granules. It demonstrates excellent film-forming properties, adhesion, and surface activity.
It is used as a dry binder for direct compression in pharmaceuticals, and as a binder for wet granulation in tablets, capsules, and granules. Its good plasticity and low glass transition temperature make it suitable for hot melt extrusion to prepare solid dispersions, enhancing drug solubility and bioavailability.
It is also an excellent moisture-sensitive binder for sensitive formulations.
Structure formula：
Appearance: White or yellowish-white powder
CDE register number: F20240000242
Application: Binder for oral preparation by wet granulation, dry granulation and direct compression;
Film-forming for film coating; Solubilizer for solid dispersion.
PVP VA64 | |
pH value | 3.0-7.0 |
K Value | 25.2-30.8 |
Aldehydes(ppm) | ≤500 |
Peroxides(ppm) | ≤400 |
Hydrazine(ppm) | ≤1 |
Monomers(Residue VP+Residue VA) (%) | 0.001 |
Impurity A(2-Pyrrolidone) (%) | ≤0.5 |
Loss on Drying (%) | ≤5.0 |
Sulphated Ash(%) | ≤0.1 |
Heavy Metals(ppm) | ≤20 |
VA content (%) | 35.3-42 max. |
Nitrogen (%) | 7.0-8.0 |
All products comply with Ph. Eur, USP/NF, JP,BP certificate of analysis.
The pH value ranges from 3.0 to 7.0. The K Value is between 25.2 and 30.8. Aldehydes content is measured at less than 500 parts per million (ppm). The level of peroxides is kept below 400 ppm.
The hydrazine content is at or below 1 ppm. The percentage of monomers, which include residue VP and residue VA, is 0.001%.
Impurity A, specifically 2-Pyrrolidone, should be no more than 0.5%. The loss on drying is specified to be less than or equal to 5.0%.
The sulphated ash content must be less than or equal to 0.1%. Heavy metals content is restricted to a maximum of 20 ppm. The VA content is between 35.3% and 42%, with the maximum being 35.3-42%.
Lastly, the nitrogen content varies from 7.0 to 8.0%.
Our products are carefully packaged to ensure safety and maintain quality during transit and storage. They are typically packed in robust 25 kg plastic drums or fiber drums, each lined with protective PE (polyethylene) bags to prevent moisture absorption and contamination. We understand that different customers may have unique packaging needs, and we are happy to accommodate special requests to meet those requirements.
For storage, it is important to keep the products in tight containers to maintain their integrity. This helps to prevent exposure to air and moisture, which could affect the product's performance. We recommend storing the drums in a cool, dry place away from direct sunlight and extreme temperatures. Proper storage conditions will help ensure that the product remains effective and consistent over time.
Additionally, clear labeling is provided on each package to include important information such as batch number, expiration date, and handling instructions. This ensures that users can easily identify and manage their inventory effectively. We are committed to providing not only high-quality products but also reliable and convenient packaging and storage solutions to meet our customers' needs.
