PVP-K Homopolymer Series / Povidone

Properties

Nontoxic; Non-irritant; Hygroscopic; Freely soluble in water, alcohol and most other organic solvents; Very slightly soluble in acetone; Excellent solubility; Film-forming; Chemical stability; Physiologically inert; Complexation and binding property. Specification Based on the polymer molecular weight and viscosity in water, the current series products are classified based on their K-values . K-value is calculated by determining the polymer relative viscosity in water and applying the results to the Fikentscher equation.

Specifications

Pharmaceutical Grade (USP/EP/BP)

Item
K value
Impurity A(NYP) ppm
Impurity B(a-p) %
Moisture %
pH
(10% in water)
Residue on Ignition %
Nitrogen content %
Limit of aldehydes ppm
Heavy Metals ppm
Peroxide ppm
Limit of hydrazine ppm
Formic acid %
K30 (powder)
27-32
≤10
≤3.0
≤5.0
3-5
≤0.1
11.5-12.8
≤500
≤10
≤400
≤1
≤0.5
K90 (powder)
85-100
≤10
≤3.0
≤5.0
4-7
≤0.1
11.5-12.8
≤500
≤10
≤400
≤1
≤0.5

Cosmetic Grade

Item
K value
Vinylpyrrolidone %
Moisture %
Solid %
PH (10% in water)
Heavy metals ppm
K30 (powder)
27 – 33
≤ 0.01
-
30 ± 1
5 – 9
≤ 20
K90 (powder)
85 – 100
≤ 0.01
≤ 5.0
≥ 95
4 – 7
≤ 20

Applications

KoVidone® K series products possess excellent binding, film-forming, dispersing and thickening properties and are widely used in the following dosage forms:
• Binder: suitable for wet and dry granulation and direct compression in tableting, improves particle compressibility and can be added to powder blends in dry or granulated forms by the addition of water, alcohol or hydro-alcoholic solutions.
• Solubilizer: suitable for oral and parenteral formulations, enhancing the solubility of poorly soluble drugs in solid dispersion forms.
• Coating agent or binder: coating of active pharmaceutical ingredients on a support structure.
• Suspending, stabilizing or viscosity-modifying agent: suitable for topical and oral suspension and solution applications. The solubility of poorly soluble drugs may be enhanced by combining with KoVidone.