CAS NO.9003-39-8
Product type: Water-soluble polymer
Chemical name:Polyvinylpyrrolidone
USP/EP name:Povidone
INC/CTFA name:PVP
Molecular formula:(C₆H₉NO)n
Ingredients: PVP, water, thickener, etc.
Features: Transparent, high viscosity aqueous liquid.
Polyvinylpyrrolidone is a colorless, odorless, water-soluble polymer with a variety of molecular weights.
Characteristic
Good solubility: PVP has good solubility in water and various organic solvents, can dissolve quickly, and is suitable for a variety of drug preparations.
Biocompatibility: PVP is a safe excipient that is not easy to cause immune response and is suitable for products that come into direct contact with the human body, such as injections and oral preparations.
Film-forming property: It can form a uniform film on the surface of the drug, which plays a protective role and controls the release rate of the drug.
Solubilization: For some poorly soluble drugs, PVP can improve their water solubility and increase bioavailability.
Adhesion: It has good adhesion properties, which helps the stable release of drugs in the body, especially in tablets and capsules.
Specification
| DMF FILE NO. | 33506 | 33415 | 32698 | 33592 | ||
| SUNVIDONE | K12 | K15 | K17 | K25 | K30 | K90 |
| Colour(5%in water)min | BY6,B₆ | BY6,B₆ | BY6,B₆ | BY6,B₆ | BY6,B₆ | BY₆,B₆ |
| K value | 10.2-13.8 | 12.8-17.3 | 15.3-18.4 | 22.5-27.0 | 27.0-32.4 | 81.0-97.2 |
| Impurity A,ppm max | 10 | 10 | 10 | 10 | 10 | 10 |
| Impurity B,%max | 3 | 3 | 3 | 3 | 3 | 3 |
| Formic Acid.%max | 0.5 | 0.5 | 0.5 | 0.5 | 0.5 | 0.5 |
| Peroxides,ppm max | 400 | 400 | 400 | 400 | 400 | 400 |
| Aldehyde,ppm max | 500 | 500 | 500 | 500 | 500 | 500 |
| Hydrazine,ppm max | 1 | 1 | 1 | 1 | 1 |
Application
Binders: used in the production of tablets and capsules to enhance drug molding and stability.
Solubilizers: increase the solubility of water-insoluble drugs and improve bioavailability.
Coating materials: used to control drug release rate and improve stability.
Suspending agents: ensure uniform distribution of liquid drug ingredients to prevent precipitation.
Stabilizers: extend the shelf life of drugs and prevent degradation.
FAQ
1.Is PVP safe?
PVP is considered a safe excipient with good biocompatibility. It has been certified by multiple international pharmacopoeias and is suitable for use in various pharmaceutical preparations.
2. How does the molecular weight of PVP affect its performance?
The molecular weight of PVP affects its solubility, adhesion, and film-forming properties. Generally speaking, a higher molecular weight may enhance its adhesion and film-forming ability, but the specific choice should be determined based on application requirements.
3. Is PVP suitable for all types of drugs?
Although PVP is suitable for most drugs, compatibility testing is still required for certain specific ingredients to ensure that it does not affect the stability and effectiveness of the drug.
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