Sodium Hypochlorite Topical Solution
» Sodium Hypochlorite Topical Solution contains not less than 0.20 g and not more than 0.32 g of Sodium Hypochlorite (NaClO) in 1000 mL of Topical Solution. Prepare Sodium Hypochlorite Topical Solution as follows (see Pharmaceutical Compounding—Nonsterile Preparations 795):
Sodium Hypochlorite Solution 5.0 mL
Monobasic Sodium Phosphate
1.02 g
Dibasic Sodium Phosphate anhydrous 17.61 g
Purified Water, a sufficient
quantity to make
1000 mL
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 make the product measure 1000 mL, and mix to produce the Topical Solution.
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 recently acquired.
Packaging and storage— Preserve in tight, light-resistant 1-liter plastic containers, and store at controlled room temperature.
Labeling— Label it to indicate that its strength is 0.025 percent, and to state the correct beyond-use date. [note—For external use only; it may be applied to wounds and burns.]
pH 791: between 7.8 and 8.2.
Beyond-use date— Seven days after the day on which it was compounded.
Assay— Transfer 50.0 mL of the Solution to a glass-stoppered flask, and add 0.5 g of potassium iodide and 10 mL of 6 N acetic acid. Titrate the liberated iodine with 0.1 N sodium thiosulfate VS, adding 2 mL of starch TS as the endpoint is approached. Perform a blank determination and make any necessary correction. Each mL of 0.1 N sodium thiosulfate is equivalent to 3.722 mg of NaClO.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Rick G. Schnatz
Manager, Compounding Pharmacy Expert Committee
(CRX05) Compounding Pharmacy05
USP32–NF27 Page 3577
Pharmacopeial Forum: Volume No. 28(2) Page 366