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1、IbuprofenC13H18O2 206.28Benzeneaceticacid, -methyl-4-(2-methylpropyl),(±)-. (±)-p-Isobutylhydratropicacid. (±)-2-(p-Isobutylphenyl)propionicacid [15687-27-1].(±)Mixture [58560-75-1].»Ibuprofencontainsnotlessthan97.0percentandnotmorethan103.0percentofC13H18O2,cal
2、culatedontheanhydrousbasis.Packagingandstorage— Preserveintightcontainers.USPReferencestandards 11— USPIbuprofenRS. USPIbuprofenRelatedCompoundCRS.Identification—A: InfraredAbsorption 197M—Donotdryspecimens.B: UltravioletAbsorption 197U—Solution: 250µgpermL.Medi
3、um: 0.1Nsodiumhydroxide.Respectiveabsorptivitiesat264nmand273nm,calculatedontheanhydrousbasis,donotdifferbymorethan3.0%.C: Thechromatogramofthe Assaypreparation obtainedasdirectedinthe Assay exhibitsamajorpeakforibuprofen,theretentiontimeofwhich,relativetothatof
4、theinternalstandard,correspondstothatexhibitedinthechromatogramofthe Standardpreparation, obtainedasdirectedinthe Assay.Water, MethodI 921: notmorethan1.0%.Residueonignition 281: notmorethan0.5%.Heavymetals, MethodII 231: 0.002%.Chromatographicpurity—Mobilephase
5、— Prepareasuitablefilteredmixtureofwater,previouslyadjustedwithphosphoricacidtoapHof2.5andacetonitrile(1340:680).Makeadjustmentsifnecessary(see SystemSuitability under Chromatography 621).Testpreparation— PrepareasolutionofIbuprofeninacetonitrilecontainingabout5
6、mgpermL.Resolutionsolution— PrepareasolutioninacetonitrilecontainingineachmLabout5mgofIbuprofenand5mgofvalerophenone.Chromatographicsystem (see Chromatography 621)— Theliquidchromatographisequippedwitha214-nmdetectoranda4-mm×15-cmcolumnthatcontains5-µmpackingL1a
7、ndismaintainedat30±0.2.Theflowrateisabout2mLperminute.Chromatographaseriesof5-µLinjectionsofthe Testpreparation toconditionthecolumn.Chromatographthe Resolutionsolution, andrecordthepeakresponsesasdirectedfor Procedure: therelativeretentiontimesareabout0.8forval
8、erophenoneand1.0foribuprofen,andtheresolution, R, betweenthevalerophenonepeakandtheibuprofenpeakisnotlessthan2.0.Procedure— [NOTE—Usepeakareaswherepeakresponsesareind
