Products – Anmol Chemicals Private Limited
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
We Manufacture Bulk Dugs/API, Excipients, pharmaceuticals (IP/BP/USP/NF/PH. EUR./JP), Speciality Chemicals (Pure/AR/ACS), mineral fortifiers (FCC). our manufacturing facility is GLP, GMP (FDA) approved, ISO 9001, ISO 14001, ISO 22000, FSSC 22000, FSSAI, kosher, halal, COPP and WHO-GMP certified.
Good Manufacturing Practice Certified by World Health Organization (WHO-GMP)
Written Confirmation Certification (WC)
Good Manufacturing Practice (EXCiPACT cGMP)
Good Manufacturing Practice (cGMP)
Good Laboratory Practice (GLP)
