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Hydrogen Peroxide Topical Solution
H2O2
Hydrogen peroxide. Hydrogen peroxide » Hydrogen Peroxide Topical Solution contains, in each 100 mL, not less than 2.5 g and not more than 3.5 g of H2O2. It contains not more than 0.05 percent of a suitable preservative or preservatives.
Packaging and storage
Preserve in tight, light-resistant containers, at controlled room temperature.
Identification
Shake 1 mL with 10 mL of water containing 1 drop of 2 N sulfuric acid, and add 2 mL of ether: the subsequent addition of a drop of potassium dichromate TS produces an evanescent blue color in the water layer which upon agitation and standing passes into the ether layer.
Acidity
To 25 mL add phenolphthalein TS, and titrate with 0.10 N sodium hydroxide: not more than 2.5 mL is required for neutralization.
Barium
To 10 mL add two drops of 2 N sulfuric acid: no turbidity or precipitate is produced within 10 minutes.
Heavy metals
Limit of nonvolatile residue
Evaporate 20 mL, previously shaken, on a steam bath to dryness, and dry the residue at 105
Limit of preservative
Extract 100 mL of well-mixed Topical Solution in a separator with a mixture of 3 volumes of chloroform and 2 volumes of ether, using 50 mL, 25 mL, and 25 mL, respectively. Evaporate the combined extracts at room temperature in a tared glass dish to dryness, and dry over silica gel for 2 hours: the residue, if any, weighs not more than 50 mg (0.05%).
Assay
Pipet 2 mL of Topical Solution into a suitable flask containing 20 mL of water. Add 20 mL of 2 N sulfuric acid, and titrate with 0.1 N potassium permanganate VS. Each mL of 0.1 N potassium permanganate is equivalent to 1.701 mg of H2O2.
Auxiliary Information
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USP32NF27 Page 2587
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