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Sodium Hypochlorite Topical Solution
»Sodium Hypochlorite Topical Solution contains not less than 0.20g and not more than 0.32g of Sodium Hypochlorite (NaClO)in 1000mLof Topical Solution.Prepare Sodium Hypochlorite Topical Solution as follows (see Pharmaceutical Compounding—Nonsterile Preparations á795ñ):
Dissolve the Dibasic Sodium Phosphate anhydrous and the Monobasic Sodium Phosphate monohydrate in about 500mLof Purified Water.Add the Sodium Hypochlorite Solution and sufficient Purified Water to make the product measure 1000mL,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 0.025percent,and to state the correct beyond-use date.[NOTE—For external use only;it may be applied to wounds and burns.]
pHá791ñ:
between 7.8and 8.2.
Beyond-use date—
Seven days after the day on which it was compounded.
Assay—
Transfer 50.0mLof the Solution to a glass-stoppered flask,and add 0.5g of potassium iodide and 10mLof 6Nacetic acid.Titrate the liberated iodine with 0.1Nsodium thiosulfate VS,adding 2mLof starch TSas the endpoint is approached.Perform a blank determination and make any necessary correction.Each mLof 0.1Nsodium thiosulfate is equivalent to 3.722mg of NaClO.
Auxiliary Information—
Staff Liaison:Claudia C.Okeke,Ph.D.,Associate Director
Expert Committee:(CRX)Compounding Pharmacy
USP28–NF23Page 1786
Pharmacopeial Forum:Volume No.28(2)Page 366
Phone Number:1-301-816-8243
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