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Povidone-IodineOphthalmicSolution s
(0.4% 1.0%)
1.Formulation
No.1=0.4%No.2=1.0%
PVP-Iodine30/06........................................0.40g1.00g Potassiumiodide.........................................0.20g0.50g Potassiumiodate......................................44.8mg0.11g Sodiumchloride..........................................1.74g–
SodiumhydroxideSolution ,0.01molar.........0.05g–
Water........................................................97.56g98.39g 2.Manufacturing DissolvePVP-IodineslowlyintheSolution ofthesalts.
3.PropertiesoftheSolution s
Clear,brownliquidoflowviscosity.
4.ChemicalstabilityofformulationNo.1(Stresstestat52C)
InitialAfter14
days
pH...................................................................6.26.7
Availableiodine.........................................0.055%0.053%
Lossofiodine.....................................................–3.6%
Freeiodine...............................................1.9ppml.9ppm
5. Chemical stability of formulation No. 2 (Stress test at 52 C)
Initial After 14
days
pH...................................................................6.3 7.2
Available iodine ...........................................0.15% 0.16%
Loss of iodine .....................................................– 0%
Free iodine ...............................................1.9 ppm 2.2 ppm
关键字:povidone iodine ophthalmic
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