Sodium Hypochlorite Compounded Topical Solution

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

DOWNLOAD PDF HERE

1 DEFINITION

Sodium Hypochlorite Compounded Topical Solution contains NLT 0.20 g and NMT 0.32 g of sodium hypochlorite (NaClO) in 1000 mL of Topical Solution.

Prepare Sodium Hypochlorite Compounded Topical Solution as follows (see Pharmaceutical Compounding—Nonsterile Preparations 〈795〉).

Dissolve the Dibasic Sodium Phosphate, anhydrous and the Monobasic Sodium Phosphate, monohydrate in about 500 mL of Purified Water. Add the Sodium Hypochlorite Solution and sufficient Purified Water to bring the preparation to final volume, and mix.

[Note—The source of the Sodium Hypochlorite Solution may be commercial unscented laundry bleach, nominally 5.25% (w/v) provided that the commercial laundry bleach was acquired recently.]

2 ASSAY

Procedure

Sample: 50.0 mL

Titrimetric system

Mode: Direct titration

Titrant: 0.1 N sodium thiosulfate VS

Endpoint detection: Visual

Analysis: To the Sample in a glass-stoppered flask add 0.5 g of potassium iodide and 10 mL of 6 N acetic acid. Titrate the liberated iodine with Titrant, adding 2 mL of starch TS as the endpoint is approached. Perform a blank determination and make any necessary correction.

Each mL of Titrant is equivalent to 3.722 mg of sodium hypochlorite (NaClO).

Acceptance criteria: 0.20–0.32 g in 1000 mL

3 SPECIFIC TESTS

pH 〈791〉: 7.8–8.2

4 ADDITIONAL REQUIREMENTS

Packaging and Storage: Package in tight, light-resistant, 1-L plastic containers, and store at controlled room temperature.

Beyond-Use Date: NMT 7 days after the date on which it was compounded when stored at controlled room temperature

Labeling: Label it to indicate that its strength is 0.025%, and to state the Beyond-Use Date. [Note—For external use only; it may be applied to wounds and burns.]