Description
A linear soluble homopolymer of N-vinyl-2-pyrrolidone and the standard polymeric binder of wet-granulation tablet manufacturing. Also used as a film former in coating premixes, a solubility enhancer in solid dispersions, and a complexing agent in liquid formulations.
White to slightly yellowish free-flowing powder, freely soluble in water and in many organic solvents (alcohols, glycerol, glycols, chloroform). Solution viscosity is determined by the K-value, with K30 being the workhorse pharmaceutical binder grade.
We supply pharmaceutical-grade Povidone from manufacturers in China holding ISO, GMP, USP/EP/JP DMF, Halal, Kosher, and other certifications relevant to the product and production.
Common market grades are differentiated by K-value: K12 and K17 (low molecular weight, used in solid dispersions and ophthalmic preparations), K25 and K30 (medium molecular weight, the dominant tablet binder grades), and K60, K90, and K120 (high molecular weight, used as viscosity builders, film formers, and in sustained-release matrix systems).
Bulk and reduced-MOQ shipments. Batch-level COA covering identification, K-value, residual N-vinyl-2-pyrrolidone monomer, peroxides, loss on drying, sulfated ash, heavy metals, and microbiology against USP, EP, JP, and BP monographs.
Introduction
Povidone was developed in Germany during the 1930s and 1940s by Walter Reppe and his colleagues at IG Farben, originally as a blood-plasma extender during the Second World War. The polymer was subsequently developed for pharmaceutical use and became the dominant tablet binder of the modern wet-granulation era.
Production proceeds by free-radical polymerization of N-vinyl-2-pyrrolidone in aqueous medium, with chain length controlled by initiator level and temperature to deliver the specified K-value. The crude polymer is purified, spray dried, and milled to defined particle size.
Listed in USP-NF, EP, JP, and BP monographs. FDA Inactive Ingredient Database listed for oral, ophthalmic, topical, parenteral, and otic routes.
The pharmacopoeial monograph specifies residual N-vinyl-2-pyrrolidone monomer below 10 mg/kg as the principal impurity control, reflecting the carcinogenicity classification of the monomer. Peroxide levels are also specified because peroxide impurities can oxidize sensitive APIs in solid dispersions and in wet granulation.
Strategic position: Povidone K30 is the single most widely used polymeric binder in solid-dose pharmaceutical wet granulation, and Povidone K90 is one of the most widely used film formers and solubility enhancers. K-value selection is the principal grade-determining choice for any given formulation.
Where it is used
- Tablet binder in wet-granulation processes (typical 2 to 5 percent in granulation solution)
- Dry binder in direct-compression tablet manufacturing
- Film former in tablet coating premixes
- Solubility enhancer for poorly soluble APIs in solid dispersions
- Viscosity builder in ophthalmic and topical liquid formulations
- Complexing agent for iodine and other actives
- Lyophilization scaffold and cryoprotectant
- Suspending and dispersing agent in pharmaceutical liquids
Technical data
| Item | Specification |
|---|---|
| Appearance | White to slightly yellowish free-flowing powder |
| Compliance | USP/NF, EP, JP, BP current edition |
| Identification | Conforms to pharmacopoeial tests |
| K-value (declared) | K30 (27 to 33), other K-values per grade |
| Residual N-vinyl-2-pyrrolidone | ≤ 10 mg/kg |
| Peroxides (as H2O2) | ≤ 400 mg/kg |
| Loss on drying | ≤ 5.0% |
| Sulfated ash | ≤ 0.1% |
| pH (5% solution) | 3.0 to 7.0 |
| Nitrogen content | 11.5% to 12.8% |
| Aldehydes (as acetaldehyde) | ≤ 500 mg/kg |
| Heavy metals (as Pb) | ≤ 10 mg/kg |
| Particle size | Per grade specification |
| Total aerobic count | ≤ 100 CFU/g |
| Yeast and mould | ≤ 50 CFU/g |
| E. coli, Salmonella | Absent |
| Source | Synthetic linear poly(N-vinyl-2-pyrrolidone) |
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