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Chemical name: Insoluble Polyvinylpyrrolidone
USP/EP name: Crospovidone
Synonyms: Crospovidonum; crosslinked PVP
INCCTFA name: Insoluble PVP
Grade: Food grade
CAS NO.25249-54-1
Molecular formula: (C₆H₉NO)n
Use: As a disintegrant
Trade name: Sunvidone CL
Characteristics
- PVPP/Crospovidone is insoluble in water, which allows it to quickly come into contact with liquid and play a disintegrating role.
- As a pharmaceutical excipient, PVP is generally non-toxic and meets the safety standards of food and drugs.
- PVP is compatible with a variety of active ingredients and will not affect other properties and effects of drugs.
- A slight characteristic odour and are practically tasteless.
- Insoluble in all the usual solvents.
Specification
| Identification | Type A | Type B | |||||
| Particle size,sieving | 15%min. | 15%max. | |||||
| residue fraction | |||||||
| (63microns sieve) | |||||||
| Water,%max. | 5 | 5 | |||||
| Sulphate ash,%max | 0.1 | 0.1 | |||||
| Water-soluble substances,%max. | 1.5 | 1.5 | |||||
| Heavy metals,ppm max. | 10 | 10 | |||||
| Vinylpyrrolidone,ppm max | 10 | 10 | |||||
| Peroxides(as H₂O₂),ppm max. | 400 | 1000 | |||||
| Nitrogen,% | 11.0-12.8 | 11.0-12.8 | |||||
Application
- Tablets and capsules: PVP is often used as a disintegrant in solid preparations to help drugs quickly release active ingredients in the body.
- Chewable tablets: Particularly suitable for dosage forms such as chewable tablets that need to disintegrate and release drugs quickly.
- Oral liquid preparations: In some liquid drugs, PVP can be used as an auxiliary ingredient to stabilize the structure of the liquid.
- Biological products: PVP is also used in the formulation of some biological products to help maintain the stability of the product and promote its absorption in the body.
FAQ
1.What are the advantages of PVPP as a disintegrant?
Good solubility: PVP is highly soluble in water, can quickly contact with liquid and promote drug disintegration.
High stability: PVP has strong chemical stability and can remain stable over a wide pH range.
2. How safe is PVPP as a disintegrant?
It is non-toxic and has no side effects at the prescribed dosage.
3. What is the optimal dosage of PVPP?
It usually depends on the specific formulation of the drug and the required disintegration effect. Generally speaking, the amount of PVP used is usually between 1% and 10%, which needs to be adjusted according to the characteristics of the drug and the formulation requirements.
4. Can PVPP be used with other excipients?
It can be used with a variety of excipients, such as fillers, adhesives, flow agents, etc. It is compatible with most drug excipients, so it can be flexibly used in various drug formulations.
5. What are the storage and handling conditions of PVPP?
It should be stored in a dry, cool environment, away from direct sunlight and high temperatures. Make sure the container is sealed to avoid moisture absorption.
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