H2O2 34.01

Hydrogen peroxide.
Hydrogen peroxide [7722-84-1].

Packaging and storage— Preserve in tight,light-resistant containers,at controlled room temperature.

Identification— Shake 1mLwith 10mLof water containing 1drop of 2Nsulfuric acid,and add 2mLof ether:the subsequent addition of a drop of potassium dichromate TSproduces an evanescent blue color in the water layer which upon agitation and standing passes into the ether layer.

Acidity— To 25mLadd phenolphthalein TS,and titrate with 0.10Nsodium hydroxide:not more than 2.5mLis required for neutralization.

Barium— To 10mLadd two drops of 2Nsulfuric acid:no turbidity or precipitate is produced within 10minutes.

Heavy metals á231ñ— Dilute 4mL,previously shaken,with 20mLof water,add 2mLof 6Nammonium hydroxide,and gently boil the solution until the volume is reduced to about 5mL.Dilute with water to 25mL:the limit is 5ppm.

Limit of nonvolatile residue— Evaporate 20mL,previously shaken,on a steam bath to dryness,and dry the residue at 105for 1hour:the weight of the residue does not exceed 30mg.

Limit of preservative— Extract 100mLof well-mixed Topical Solution in a separator with a mixture of 3volumes of chloroform and 2volumes of ether,using 50mL,25mL,and 25mL,respectively.Evaporate the combined extracts at room temperature in a tared glass dish to dryness,and dry over silica gel for 2hours:the residue,if any,weighs not more than 50mg (0.05%).

Assay— Pipet 2mLof Topical Solution into a suitable flask containing 20mLof water.Add 20mLof 2Nsulfuric acid,and titrate with 0.1Npotassium permanganate VS.Each mLof 0.1Npotassium permanganate is equivalent to 1.701mg of H2O2.

Expert Committee:(PA7)Pharmaceutical Analysis 7

USP28–NF23Page 972

Phone Number:1-301-816-8394