PVPP Cas 25249-54-1
Specification
Items | Specifications | Results |
Appearance | Hygroscopic, white or yellowish-white powder or flakes. | White powder |
Solubility | Insoluble in water,in ordinary organic solvents. | Complies |
Identification | A,B,C,D | Complies Type B |
PH(in 1% suspension) | 5.0-8.0 | 6.7 |
Loss on drying | ≤5.0% | 1.8% |
Nitrogen content | 11.0-12.8 | 12.2 |
Peroxides | ≤1000ppm | 240ppm |
Vinylpyrrolidinone | ≤10ppm | 2.4ppm |
Residue on ignition | ≤0.1% | 0.06% |
Heavy metals | ≤10ppm | Complies |
Water-soluble substances | ≤1.5% | 0.36% |
Particle size | 30-60μm | Complies |
Residual Solvent | Meet with requirement | Complies |
Total aerobic counts | ≤100cfu/g | ＜100cfu/g |
Total combined yeast and mold | ≤10cfu/g | ＜10cfu/g |
E.Coli | Absence/lg | Complies |
Salmonella spp | Absence/lg | Complies |
Pseudomona aerugonosa | Absence/lg | Complies |
Staphylococus aureus | Absence/lg | Complies |
Conclusion | The product complies with enterprise standard. |
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1. Chemical Identity and Structure
Chemical Name: Cross-linked Polyvinylpyrrolidone (PVPP)
CAS Number: 9003-39-8
Monomer: The base unit is N-Vinylpyrrolidone.
Polymerization: It is produced by the bridging polymerization of N-Vinylpyrrolidone. This "bridging" or cross-linking is the key to its properties.
2. The Concept of Cross-Linking
This is the most important chemical concept to understand:
Regular Povidone (PVP): Made by polymerizing N-Vinylpyrrolidone into long, linear chains. These chains are water-soluble.
Crospovidone (PVPP): During its manufacturing, "cross-linking agents" (often compounds with two double bonds) create bridges that chemically tie these long chains together into a vast, three-dimensional network.
This cross-linked structure is why it's insoluble. While water can penetrate the network and cause it to swell, the chemical bonds holding the network together are too strong to allow the individual polymer chains to break away and dissolve.
The simplified chemical structure of its repeating unit is:
O
║
[N-(C₃H₆)-C] (Within a polyvinyl backbone)
|
(CH₂-CH)_n
3. Key Chemical and Functional Properties
| Property | Chemical Reason | Functional Consequence |
|---|
| Insolubility | The extensive, covalently bonded 3D network. | Does not form a gel or sticky solution; remains as discrete particles. |
| High Swelling Capacity | The polymer chains are hydrophilic (water-loving) and repel each other when hydrated, but are held in place by cross-links. | Absorbs water and expands rapidly, exerting immense swelling pressure. |
| Capillary Action | The dry powder has a fine, porous particle structure. | Draws water into a tablet very quickly via capillaries, enhancing the swelling effect. |
| Chemically Inert | The polyvinylpyrrolidone structure is stable and non-reactive. | Does not interact with the active pharmaceutical ingredients (APIs), ensuring drug stability. |
4. Primary Function: Tablet Disintegration
This is almost exclusively why Crospovidone is used. The mechanism is physical and mechanical:
Water Uptake: When a tablet containing Crospovidone is exposed to water (in the stomach or a dissolution vessel), the Crospovidone particles act like microscopic sponges, drawing water into the tablet through capillary action.
Swelling: The Crospovidone particles absorb the water and swell dramatically in volume.
Pressure Generation: This swelling creates enormous, radially outward stress within the tightly compressed tablet matrix.
Breakup: This internal stress overcomes the bonding forces holding the tablet together, causing it to break apart rapidly into smaller granules and primary powder particles. This process is known as disintegration.
This is crucial because disintegration is the first step before the drug can dissolve and be absorbed by the body.
Summary
| Aspect | Description |
|---|
| What it is | An insoluble, cross-linked polymer of N-vinylpyrrolidone. |
| Chemical Key | The 3D network created by cross-linking, which prevents dissolution but allows swelling. |
| Primary Role | A super-disintegrant in pharmaceutical tablets and capsules. |
| Mechanism | Acts by capillary action and swelling, breaking tablets apart through physical pressure. |
| Advantage | Highly effective at low concentrations (typically 2-5% of tablet weight), inert, and does not gel. |
In essence, from a chemical perspective, Crospovidone is an ingeniously designed polymer whose insolubility is its greatest asset. Its cross-linked structure allows it to perform a critical physical function—rapidly breaking apart tablets—without chemically interfering with the medicine itself.
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