Hydrogen Peroxide Topical Solution
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
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H2O2 34.01
Hydrogen peroxide CAS RN®: 7722-84-1.
1 DEFINITION
Hydrogen Peroxide Topical Solution contains, in each 100 mL, NLT 2.5 g and NMT 3.5 g of hydrogen peroxide (H2O2 ). It contains NMT 0.05% of a suitable preservative or preservatives.
2 IDENTIFICATION
Sample: 1 mL
Analysis: Shake the Sample with 10 mL of water containing 1 drop of 2 N sulfuric acid, and add 2 mL of ether. Subsequently add a drop of potassium dichromate TS.
Acceptance criteria: The addition of potassium dichromate TS produces an evanescent blue color in the water layer, which upon agitation and standing passes into the ether layer.
3 ASSAY
Procedure
Sample: 2 mL
Titrimetric system
Mode: Direct titration
Titrant: 0.1 N potassium permanganate VS
Endpoint detection: Visual
Analysis: Pipet the Sample into a suitable flask containing 20 mL of water. Add 20 mL of 2 N sulfuric acid, and titrate with Titrant. Each mL of 0.1 N potassium permanganate is equivalent to 1.701 mg of hydrogen peroxide (H2O2 ).
Acceptance criteria: 2.5–3.5 g in 100 mL
4 IMPURITIES
Barium
Sample: 10 mL
Analysis: To the Sample add two drops of 2 N sulfuric acid.
Acceptance criteria: No turbidity or precipitate is produced within 10 min.
Limit of Nonvolatile Residue
Sample: 20 mL, previously shaken
Analysis: Evaporate the Sample on a steam bath to dryness, and dry the residue at 105° for 1 h.
Acceptance criteria: NMT 30 mg of the residue
5 SPECIFIC TESTS
Acidity
Sample: 25 mL
Analysis: To the Sample add phenolphthalein TS, and titrate with 0.10 N sodium hydroxide.
Acceptance criteria: NMT 2.5 mL is required for neutralization.
Limit of Preservative
Sample: 100 mL, well mixed
Diluent: Chloroform and ether (3:2)
Analysis: Extract the Sample in a separator with Diluent, using 50, 25, 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 h.
Acceptance criteria: 0.05%; the residue, if any, weighs NMT 50 mg.
6 ADDITIONAL REQUIREMENTS
Packaging and Storage: Preserve in tight, light-resistant containers, at controlled room temperature.
