Hydrous Benzoyl Peroxide
Click to View Image
C14H10O4(anhydrous) 242.23

Peroxide,dibenzoyl.
Benzoyl peroxide [94-36-0].
»Hydrous Benzoyl Peroxide contains not less than 65.0percent and not more than 82.0percent of C14H10O4.It contains about 26percent of water for the purpose of reducing flammability and shock sensitivity.
Caution—Hydrous Benzoyl Peroxide may explode at temperatures higher than 60or cause fires in the presence of reducing substances.Store it in the original container,treated to reduce static charges.
Packaging and storage— Store in the original container,at room temperature.[NOTE—Do not transfer Hydrous Benzoyl Peroxide to metal or glass containers fitted with friction tops.Do not return unused material to its original container,but destroy it by treatment with sodium hydroxide solution (1in 10)until addition of a crystal of potassium iodide results in no release of free iodine.]
Identification—
A: Prepare a solution in methanol to contain 10mg of benzoyl peroxide per mL.Apply 5µLof this solution and 5µLof a freshly prepared Standard solution of Hydrous Benzoyl Peroxide,previously subjected to the Assay,in methanol containing 10mg per mLon a line parallel to and about 2.5cm from the bottom of a thin-layer chromatographic plate (see Chromatography á621ñ)coated with a 0.25-mm layer of chromatographic silica gel mixture.Place the plate in a developing chamber containing,and equilibrated with,a mixture of toluene,dichloromethane,and glacial acetic acid (50:2:1).Develop the chromatogram until the solvent front has moved about three-fourths of the length of the plate.Remove the plate,and allow the solvent to evaporate.Observe the plate under short-wavelength UVlight:the RFvalue of the principal spot obtained from the solution under test corresponds to that obtained from the Standard solution.
B: Dissolve an accurately weighed quantity in acetonitrile to obtain a solution containing 0.32mg of benzoyl peroxide per mL.Chromatograph this test solution and a freshly prepared Standard solution of Hydrous Benzoyl Peroxide,previously subjected to the Assay,in acetonitrile containing 0.32mg per mLas directed in the test for Related compoundsunder Benzoyl Peroxide Gel:the solution under test exhibits a major peak for benzoyl peroxide,the retention time of which corresponds to that exhibited by the Standard solution.
Chromatographic purity— Calculate the area percentage of each peak in the chromatogram of the test solution prepared as directed in Identificationtest B:the sum of the areas of all peaks other than the principal peak does not exceed 2.0%of the total area,and the area of any individual peak other than the principal peak does not exceed 1.5%of the total area.
Assay— Place about 300mg of previously mixed Hydrous Benzoyl Peroxide in an accurately weighed conical flask fitted with a ground-glass stopper,and weigh again to obtain the weight of the test specimen.Add 30mLof glacial acetic acid,previously sparged with carbon dioxide for not less than 2minutes just before use,and swirl the flask gently to effect solution.Add 5mLof potassium iodide solution (1in 2),and mix.Allow the solution to stand for 1minute.Titrate the liberated iodine with 0.1Nsodium thiosulfate VS.As the endpoint is approached add 1drop of starch iodide paste TS,or equivalent,and continue the titration to the discharge of the blue color.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nsodium thiosulfate is equivalent to 12.11mg of C14H10O4.
Auxiliary Information— Staff Liaison:Behnam Davani,Ph.D.,MBA,Senior Scientist
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 236
Phone Number:1-301-816-8394