3110雌二醇乙酸盐norethindrone醋酸酯.pdfVIP

3108Estradiol/MonographsUSP35

obtainedfromtheAssaypreparationandtheStandardprepara-Mode:LC

tion,respectively.Detector:UVDualwavelength(254nm/280nm)or

equivalent

[NOTE—Theabsorptionofestradiolat280nmandnoreth-

indroneacetateat254nmcanbeincludedinasinglerun

byalteringthewavelength.]

EstradiolandNorethindroneAcetateColumn:4.6-mm×15-cm;packingL1

Flowrate:1mL/min

Tablets

[NOTE—Performaninvestiionalruntodeterminethere-

DEFINITIONtentiontimesforestradiolandnorethindroneacetate.]

EstradiolandNorethindroneAcetateTabletscontainNLT90.0%Injectionsize:50μL

andNMT110.0%ofthelabeledamountofestradiolSystemsuitability

(CHO)andNLT90.0%andNMT110.0%ofthelabeledSamp:StandardsolutionandSystemsuitabilitysolution

18242

amountofnorethindroneacetate(CHO).