Description
Polyvinylpyrrolidone (PVP) is a versatile and widely used synthetic polymer excipient renowned for its exceptional properties in the pharmaceutical industry. As a water-soluble, biocompatible, and non-toxic material, PVP offers a broad spectrum of applications in drug formulation.
In solid dosage forms, PVP serves as an effective binder, facilitating the agglomeration of drug powders and other excipients during tablet compression or capsule filling. Its binding ability ensures the formation of tablets with excellent mechanical strength and integrity, preventing capping, lamination, or breakage. Additionally, PVP can act as a film-forming agent, enabling the creation of smooth and uniform tablet coatings. These coatings not only enhance the appearance of the tablets but also protect the active pharmaceutical ingredients (APIs) from environmental factors and can be designed for modified drug release profiles.
In liquid pharmaceutical formulations such as solutions, suspensions, and emulsions, PVP functions as a stabilizer, preventing the aggregation of particles and maintaining the homogeneity of the mixture. It can also improve the solubility of poorly water-soluble drugs by forming complexes with APIs, thereby enhancing drug bioavailability. In the field of parenteral medications, PVP's low toxicity and good compatibility make it suitable for use in injectable formulations, where it can act as a solubilizer and viscosity modifier.
Specification
PVP K30
Item | USP | BP/EP | CP | |
Identification | Conforms | |||
pH | 3.0-5.0 | |||
Water (%) | ≤5.0 | |||
Residue on ignition/Sulphated Ash (%) | ≤0.1 | |||
Aldehydes | ≤0.05% | 500ppm | ≤0.05% | |
2-Pyrrolidone(%) | ≤3.0 | ≤2.0 | ||
Vinyl pyrrolidone (%) | ≤0.001 | |||
K-value | 27-32 | 28-32 | 27-32 | |
Nitrogen content (%) | 11.5-12.8 | |||
Peroxides(ppm) | ≤400 | |||
Formic Acid(%) | ≤0.5 | |||
Hydrazine(ppm) | ≤1 | |||
Lead(ppm) | 10 | —— |
| |
Heavy metal(%) | —— | ≤0.001 | ||
Hydrazinium(%) | —— | ≤0.0001 | ||
Microbial limits | Conforms |
Packaging
- PACKING: 25kg/drum
- STORAGE AND TRANSPORT: IN DRY AND COOL NORMAL TEMPERATURE
- G.W. 27.5kg