Octocrylene
C24H27NO2 361.48
2-Propenoic acid,2-cyano-3,3-diphenyl,2-ethylhexyl ester.
2-Ethylhexyl 2-cyano-3,3-diphenylacrylate [6197-30-4].
»Octocrylene contains not less than 95.0percent and not more than 105.0percent of C24H27NO2.
Packaging and storage— Preserve in tight containers.
Identification, Ultraviolet Absorption á197Uñ—
Solution: 0.1mg per mL.
Medium: methanol.
Absorptivities,calculated on the as-is basis,do not differ by more than 3.0%.
Specific gravity á841ñ: between 1.045and 1.055.
Refractive index á831ñ: between 1.561and 1.571at 20.
Acidity— Transfer 60mLof alcohol to a suitable container,add 1mLof phenolphthalein TS,and add sufficient 0.1Nsodium hydroxide to obtain a persistent pink color.Transfer 60mLof this solution to a suitable container,add about 6g of Octocrylene,accurately weighed,mix,and titrate with 0.1Nsodium hydroxide:not more than 0.18mLof titrant per g of Octocrylene is necessary to obtain a persistent pink endpoint.
Chromatographic purity—
Test solution— Use the Assay preparation.
Chromatographic system— Proceed as directed in the Assay.To evaluate the system suitability requirements,use the Standard preparationprepared as directed in the Assay.
Procedure— Inject a volume (about 1µL)of the Test solutioninto the chromatograph,record the chromatogram,and measure all of the peak responses.Calculate the percentage of each impurity in the portion of Octocrylene taken by the formula:
100(ri/rs),
in which riis the peak response for each impurity;and rsis the sum of the responses of all the peaks:not more than 0.5%of any individual impurity is found;and not more than 2.0%of total impurities is found.
Assay—
Standard preparation— Dissolve an accurately weighed quantity of USP Octocrylene RSin acetone,and dilute quantitatively,and stepwise if necessary,with acetone to obtain a solution having a known concentration of about 21.0mg per mL.
Assay preparation— Transfer about 2.1g of Octocrylene,accurately weighed,to a 100-mLvolumetric flask,dilute with acetone to volume,and mix.
Chromatographic system(see Chromatography á621ñ)— The gas chromatograph is equipped with a flame-ionization detector and a 0.32-mm ×60-m column coated with a 0.25-µm film of G1.Helium is used as the carrier gas at a flow rate of about 6mLper minute.The chromatograph is programmed as follows.Initially the temperature of the column is equilibrated at 80;upon injection,the temperature is increased at a rate of 4per minute to 280,and is held at 280for 10minutes.The injection port temperature is maintained at 300,and the detector temperature is maintained at 300.Chromatograph theStandard preparation,and record the peak responses as directed forProcedure:the resolution,R,between the octocrylene and any other peak is not less than 1.0;and the relative standard deviation for replicate injections is not more than 2.0%.
Procedure— Separately inject equal volumes (about 1µL)of theStandard preparation and theAssay preparation into the chromatograph,record the chromatograms,and measure the responses for the major peaks.Calculate the quantity,in mg,of C24H27NO2in the portion of Octocrylene taken by the formula:
100C(rU/rS),
in whichCis the concentration,in mg per mL,of USP Octocrylene RSin theStandard preparation;andrUandrSare the peak responses obtained from theAssay preparation and theStandard preparation,respectively.
Auxiliary Information— Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(PA6)Pharmaceutical Analysis 6
USP28–NF23Page 1413
Pharmacopeial Forum:Volume No.30(3)Page 905
Phone Number:1-301-816-8389
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