Hydrogen Peroxide Concentrate

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; UNII: BBX060AN9V. 

1 DEFINITION 

Hydrogen Peroxide Concentrate contains NLT 29.0% and NMT 32.0%, by weight, of hydrogen peroxide (H₂O₂). It contains NMT 0.05% of a suitable preservative or preservatives. 

[Caution—Hydrogen Peroxide Concentrate is a strong oxidant.] 

2 IDENTIFICATION 

Sample: 1 mL of Concentrate 

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 solution: Weigh about 1 mL of Concentrate in a 100-mL volumetric flask, and dilute with water to volume. Titrimetric system 

Mode: Direct titration 

Titrant: 0.1 N potassium permanganate VS 

Endpoint detection: Visual 

Analysis: To 20.0 mL of the Sample solution 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: 29.0%–32.0%, by weight 

4 IMPURITIES 

Chloride and Sulfate, Chloride 〈221〉 

Sample solution: 1.5 g of Concentrate, diluted to 25 mL 

Acceptance criteria: 50 ppm; the Sample solution shows no more chloride than 0.10 mL of 0.020 N hydrochloric acid. Limit of Nonvolatile Residue 

Sample: 20 mL of Concentrate, 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 residue 

5 SPECIFIC TESTS 

Acidity 

Sample solution: 25 g of Concentrate, diluted to 250 mL 

Analysis: To 25 mL of the Sample solution 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: 90 mL of Concentrate, well mixed 

Analysis: Extract the Sample in a separator with a mixture of chloroform and ether (3:2), 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 partially filled containers having a small vent in the closure, and store in a cool place. Labeling: Label it to indicate the name and amount of any added preservative. Label it to state that this article is not intended for direct administration to humans or animals.