| Product | Povidone K30 | |
|---|---|---|
| Appearance | White or yellowish-white, hygroscopic powder or flakes | |
| Solubility | Freely soluble in water, in alcohol (96%) and in methanol, very slightly soluble in acetone | |
| Appearance of Solution | Clearly and not more intensely colored than reference solution B6,BY6 or R6 | |
| Identifications | Meet lD Tests | |
| pH value (5% aqueous solution) | 3.0-5.0 | |
| Viscosity (expressed as K value) | 27.0-32.4 | |
| Aldehydes (Exp.as Acetaldehyde) | ≤500 ppm | |
| Peroxides(Exp. as H202) | ≤400 ppm | |
| Formic Acid | ≤0.5 % | |
| Hydrazine | ≤1 ppm | |
| Impurity A (NVP) | USP26 | ≤0.1 % |
| Impurity A (NVP) | Current USP/EP | ≤10 ppm |
| Impurity B(2-Pyrrolidone) | Current USP/EP | ≤3.0 % |
| Heavy Metals (As Pb) | ≤10 ppm | |
| Water | ≤5.0 % | |
| Sulphated Ash | ≤0.1 % | |
| Nitrogen content | 11.5-12.8 % | |
Povidone K30 is one of the most important excipients in the worldwide for pharmaceutical industry, whatever for human health care products and animal health care products:
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.
Suitable for oral and parenteral formulations, enhancing the solubility of poorly soluble drugs in solid dispersion forms.
Coating of active pharmaceutical ingredients on a support structure.
Suitable for topical and oral suspension and solution applications. The solubility of poorly soluble drugs may be enhanced by combining with Povidone.
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