| PHYSICAL AND CHEMICAL PROPERTIES
Medical Equipment
PVP-Iodine
has been reported as an effective disinfectant for such diverse items
as contact lenses, dialysis equipment, fiberscopes, endoscopes, and a
wide variety of dental and medical equipment55-61.
Toxicology
Compared to other iodine preparations, PVP-Iodine exhibits markedly
lower oral toxicity. Consequently, the accidental ingestion of
PVP-Iodine solutions is much less hazardous than from equal amounts of
available iodine solutions. For this reason, PVP-Iodine solutions do
not require the hazardous, poisonous warning labels on bottles that
iodine products must have. Moreover, animal and human exposure tests
have revealed virtually no skin reactions to PVP-Iodine, and only very
mild transitory effects on mucous membranes.
These results are in marked contrast to the effects of elemental iodine, which is a
primary irritant and sensitizer. Preparations containing elemental iodine with no PVP
frequently delay the healing of wounds by inhibiting formation of granulation tissue.
PVP-Iodine is unique in effectively minimizing or eliminating these undesirable effects.
It may be left in contact with tissue for extended periods of time with no ill effects.
Even bandages are permissible, whereas ordinary iodine preparations are not bandaged
because the iodine sublimes onto protective coverings causing pronounced irritancy to the tissue.
Safety and Efficacy
Toxicity test results, as well as usage for various medical conditions during the past
approximate thirty five years on many thousands of patients, all point to the safety and
efficacy of products containing PVP-Iodine.
| POVIDONE IODINE USP/BP/EP |
| TYPICAL CERTIFICATEOF ANALYSIS |
| TEST |
SPECIFICATION |
RESULT |
| Description |
Reddish Brown Colour Powder |
Reddish Brown Colour Powder |
| Solubility |
Soluble in water & alcohol it is practically insoluble in acetone |
Complies |
| Identification (A & B) |
A : A deep blue colour produced
B : A dry brown colour film
formed, which is readily
dessolved in water |
Complies
Complies |
| Heavy Metals |
Maximum 20 ppm |
< 20 ppm |
| Nitrogen |
9.5% to 11.5% w/w (on dried basis) |
10.40% w/w (on dried basis) |
| Iodide |
Maximum6.6% w/w |
3.78% w/w Complies |
| Sulphated Ash |
Negligible |
Complies |
| Loss on drying |
Maximum 8.0% w/w |
3.05% w/w |
| Assay |
9.0%to 12.0% w/w
(on dried basis) |
11.35% w/w of available Iodine (on dried basis) |
|
