Povidone USP
Abstract:
Polyvinylpyrrolidone (PVP), also commonly called polyvidone or povidone, is a water-soluble polymer made from the monomer N-vinylpyrrolidone
Uses/Applications:
It is used as a binder in many pharmaceutical tablets. Used as a thickening agent in tooth whitening gels. As a food additive, PVP is a stabilizer and has E number E1201. is also used in the wine industry as a fining agent for white wine and some beers.
Identity:
Product Name: Povidone
CAS No.: 9003-39-8
Specifications:
| Test | Specification |
| Characters | It occurs as a white to slightly creamy white powder, hygroscopic. |
| Identification
Test A Test B Test C Test D Test E |
a. Infrared Absorption b. Specified test. An orange-yellow precipitate is formed c. Specified test. A pale blue precipitate is formed d. Specified test. A deep red color is produced e. Specified test. The substance dissolves |
| Solubility | Freely soluble in water, in methanol, and in alcohol; slightly soluble in acetone; practically insoluble in ether |
| Residue on Ignition | Not more than 0.1% |
| Lead | Not more than 10 ppm |
| Limit of Aldehydes |
|
| Limit of Hydrazine | Not more than 1 ppm of hydrazine. |
| Vinylpyrrolidinone | Not more than 0.001% |
| 2-Pyrrolidone | Not more than 3.0% |
| Peroxides | Not more than 0.35, corresponding to not more than 400 ppm, expressed as H2O2 |
| Formic acid | Not more than 0.5% |
| pH | 3.0–5.0 for Povidone having a nominal K-value of 30 or less |
| Water | Not more than 5.0 % |
| K-Value | K-value of Povidone having a stated K-value or a stated K-value range with an average of more than 15:
90.0%–108.0% of the stated value or of the average of the stated range |
| Residual solvents | Meets the requirements |
| Assay (Nitrogen Determination Method) | Not less than 11.5% and not more than 12.8% on the anhydrous basis |
Shelf life, Storage and Packing
It should be stored in a segregated area in a cool and ventilated place away from combustible materials. Keep in a tightly closed container, sealed until ready for use. It is packed in 25kg or 50kg HDPE bags or drums as required.
Other
GLP, cGMP (FDA) Approved, ISO 9001, ISO 14001, ISO 45001, ISO 17025, ISO 22000, FSSC 22000, FSSAI, Halal and Kosher certified.
We observe WHO Good manufacturing practice and Good laboratory practice.
