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Hydrogen Peroxide Topical Solution
H2O2 34.01

Hydrogen peroxide.
Hydrogen peroxide [7722-84-1].
» 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 231 Dilute 4 mL, previously shaken, with 20 mL of water, add 2 mL of 6 N ammonium hydroxide, and gently boil the solution until the volume is reduced to about 5 mL. Dilute with water to 25 mL: the limit is 5 ppm.
Limit of nonvolatile residue— Evaporate 20 mL, previously shaken, on a steam bath to dryness, and dry the residue at 105 for 1 hour: the weight of the residue does not exceed 30 mg.
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%).
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
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— Staff Liaison : Behnam Davani, Ph.D., MBA, Senior Scientist
Expert Committee : (MDAA05) Monograph Development-Antivirals and Antimicrobials
USP29–NF24 Page 1080
Phone Number : 1-301-816-8394