POVIDONE IODINE
| Sr. |
TEST |
REQUIREMENT |
RESULT |
| 1. |
Description |
Yellowish brown or reddish brown,
amorphous powder.
|
Reddish brown amorphous
powder
|
| 2. |
Solubility |
Soluble in water and in ethanol (96%);
practically insoluble in acetone.
|
Complies |
| 3. |
Identification |
To Comply with USP tests |
Complies |
| 4. |
Loss on Drying |
Not more than 8.0%, determined on 5g by
drying in an oven at 105°C.
|
2.14% |
| 5. |
Residue on ignition |
Not more than 0.025% from 2.0 g.
|
0.018% |
| 6. |
Iodide ion
(Dried basis)
|
Not more than 6.6%
|
2.79% |
| 7. |
Heavy metals |
To Comply with USP tests
|
Complies |
| 8. |
Nitrogen Content
(Dried basis)
|
Not less than 9.5% and not more than
11.5%
|
10.47% |
| 9. |
Assay (Dried Basis)
(Available iodine)
|
Povidone iodine contains not less than
9.0% and not more than 12.0% of
available Iodine
|
10.72% |
REMARK SAMPLE CONFORMS/ DOES NOT CONFORMS AS PER ABOVE SPECIFICATION
POVIDONE IODINE
Povidone-iodine (PVP-I), brand name Pyodine and Betadine is a stable chemical complex of polyvinylpyrrolidone (povidone, PVP) and elemental iodine. It contains from 9.0% to 12.0% available iodine, calculated on a dry basis.
This unique complex was discovered in 1955 at the Industrial Toxicology Laboratories in Philadelphia by H. A. Shelanski and M. V. Shelanski. They carried out tests in vitro to demonstrate anti-bacterial activity, and found that the complex was less toxic in mice than tincture of iodine. Human clinical trials showed the product to be superior to other iodine formulations. It was immediately marketed, and has since become the universally preferred iodine antiseptic.
Povidone-iodine is a broad spectrum antiseptic for topical application in the treatment and prevention of infection in wounds. May be used in first aid for minor cuts, grazes, burns, abrasions and blisters. Following the discovery of iodine by Bernard Courtois in 1811, it has been broadly used for the prevention and treatment of skin infections, and the treatment of wounds. Iodine has been recognized as an effective broad-spectrum bactericide, and it is also effective against yeasts, molds, fungi, viruses, and protozoans. Drawbacks to its use in the form of aqueous solutions include irritation at the site of application, toxicity and the staining of surrounding tissues. These deficiencies were overcome by the discovery and use of PVP-I, in which the iodine is carried in a complexed form and the concentration of free iodine is very low.
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