Diflorasone Diacetate CAS 33564-31-7 Assay 97.0 ~ 103.0% Factory Corticosteroid

IDiflorasone Diacetate [33564-31-7]
» I-Diflorasone Diacetate iqulethe ngaphantsi kweepesenti ze-97.0 kwaye ingabi ngaphezu kwe-103.0 ipesenti ye-C26H32F2O7, ibalwa kwisiseko esomileyo.
Ukupakishwa kunye nokugcinwa-Londoloza kwizikhongozeli eziqinileyo.
Imigangatho yezalathiso ye-USP <11>-
USP Diflorasone Diacetate RS
Ukuchongwa, i-Infrared Absorption <197M>.
Ukujikeleza okuthe ngqo <781S>: phakathi +58 ° kunye +68 °.Isisombululo sovavanyo: 20 mg, i-undried, nge-mL, kwi-chloroform.
Ilahleko ekomisweni <731>-Yomise kwi-vacuum kwi-60 ° kunye noxinzelelo olungadlulanga i-5 mm ye-mer cury kwiiyure ze-16: ilahlekelwa ngaphezu kwe-0.5% yobunzima bayo.
Intsalela ekutshisweni <281>: hayi ngaphezulu kwe-0.5%
Ukucoceka kweChromatographic-
Isigaba seselula kunye nenkqubo yeChromatographic-Lungisa njengoko kuyalelwe kwi-Assay.
Isisombululo sovavanyo-Dibanisa isixa esilinganiswe ngokuchanekileyo seDiflorasone Diacetate kwikloroform ezele ngamanzi ukuze ufumane isisombululo esinoxinzelelo olumalunga ne-6 mg nge-mL.
Inkqubo-Tofa umthamo (malunga ne-10 µL) yesisombululo soVavanyo kwichromatograph, urekhode ichromatogram ixesha elilingana namaxesha ama-5 exesha lokugcinwa kwencopho enkulu, kwaye ulinganise iindawo zazo zonke iincopho.Bala ipesenti yokungahlambuluki ngakunye kwinxalenye yeDiflorasone Diacetate ethathwe ngefomula:
100(ri / rs)
apho i-ri yindawo encopho yokungcola ngakunye;kwaye rs sisimbuku seendawo zazo zonke iincopho: hayi ngaphezulu kwe-1.0% yakho nakuphi na ukungcola komntu okufunyenweyo;kwaye akukho ngaphezulu kwe-2.0% yokungcola okupheleleyo kufunyenwe.
Isivavanyi-
Isigaba seselula-Lungisa isisombululo esiqulethe umxube we-n-butyl chloride egcwele amanzi, i-methylene chloride egcwele amanzi, i-glacial acetic acid, kunye ne-tetrahydrofuran (350: 125: 15: 10).Yenza uhlengahlengiso xa kukho imfuneko (jonga ukufaneleka kweNkqubo phantsi kweChromatography <621>).
Isisombululo somgangatho wangaphakathi-Usebenzisa i-chloroform egcwele amanzi, lungiselela isisombululo se-isoflupredone acetate equlethe malunga ne-0.04 mg nge-mL.
Ulungiselelo olusemgangathweni-Nyibilikisa isixa esinomlinganiso ochanekileyo we-USP Diflorasone Diacetate RS kwisisombululo somgangatho wangaphakathi ukufumana isisombululo esinoxinzelelo olwaziwayo malunga ne-33µg nge-mL.
Ukulungiswa kovavanyo-Ukudluliselwa malunga ne-15 mg ye-Diflorasone Diacetate, ilinganiswe ngokuchanekileyo, kwi-flask ye-volumetric ye-500-mL.Yongeza isisombululo somgangatho wangaphakathi kwivolumu, kwaye udibanise.
Inkqubo yeChromatographic (jonga i-Chromatography <621>)-I-chromatograph yolwelo ixhotyiswe nge-254-nm detector kunye ne-4.6-mm × 10-cm ikholamu equlethe i-3- µm yokupakisha i-L3.Izinga lokuhamba malunga ne-2.5 mL ngomzuzu.I-Chromatograph Ukulungiswa koMgangatho, kwaye urekhode iindawo eziphakamileyo njengoko ziqondiswe kwiNkqubo: isisombululo, R, phakathi kwe-analyte kunye neencopho zomgangatho wangaphakathi ezingekho ngaphantsi kwe-12;kunye nokutenxa komgangatho onxulumeneyo ongekho ngaphantsi kweenaliti ezine eziphindaphindayo azikho ngaphezu kwe-2.0%.
Inkqubo-Ngokwahlukileyo tofa imithamo elinganayo (malunga ne-10 µL) yoLungiso oluMgangatho kunye nolungiselelo loVavanyo kwichromatograph, urekhode iichromatograms, kwaye ulinganise iindawo zeencopho ezinkulu.Amaxesha okugcinwa okuhambelanayo malunga ne-1.0 ye-diflorasone diacetate kunye ne-2.4 yomgangatho wangaphakathi.Bala ubuninzi, kwimg, ye-C 26H32F2O7 kwisahlulo seDiflorasone Diacetate esithathwe ngefomula:
0.5C(RU / RS)
apho uC lugxininiso, kwi µg ngemL, ye USP Diflorasone Diacetate RS kulungiselelo loMgangatho;kunye ne-RU kunye ne-RS yimilinganiselo yeendawo eziphakamileyo zeDiflorasone Diacetate kunye neendawo ezisemgangathweni zangaphakathi ezifunyenwe kuLungiselelo lwe-Assay kunye nokulungiswa koMgangatho, ngokulandelanayo.