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

Diflorasone Diacetate [33564-31-7]
»Diflorasone Diacetate waxay ka kooban tahay wax aan ka yarayn 97.0 boqolkiiba oo aan ka badnayn 103.0 boqolkiiba C26H32F2O7, oo lagu xisaabiyo sal engegan.
Baakadaha iyo kaydinta-Ku xafid weel cidhiidhi ah.
Heerarka Tixraaca USP <11>-
USP Diflorasone Diacetate RS
Aqoonsiga, Nuugista Infrared <197M>.
Wareeg gaar ah <781S>: inta u dhaxaysa +58° iyo +68°.Xalka tijaabada: 20 mg, aan la qallajin, halkii ml, ee chloroform.
Luminta qalajinta <731>-Ku qalaji faakuum 60 ° iyo cadaadis aan ka badnayn 5 mm of mercury 16 saacadood: waxay luminaysaa wax aan ka badnayn 0.5% miisaankeeda.
Hadhaaga dabka <281>: in aan ka badnayn 0.5%
Daahirnimada Chromatographic-
Marxaladda wareegta iyo nidaamka Chromatographic-U diyaari sida lagu faray Imtixaanka.
Tijaabada xal-ku milmi tirada saxda ah ee la miisaamay ee Diflorasone Diacetate ee chloroform-ka biyaha ka buuxaan si loo helo xal isagoo ku urursan qiyaastii 6 mg halkii ml.
Habka-Ku dur mugga (qiyaastii 10 µL) ee xalka Tijaabada chromatograph-ka, ku qor chromatogramka muddo u dhigma 5 jeer wakhtiga haynta ee ugu sarreysa, oo cabbir aagagga dhammaan meelaha ugu sarreeya.Xisaabi boqolkiiba wasakh kasta ee qaybta Diflorasone Diacetate ee ay qaadatay qaacidada:
100 (ri / rs)
taas oo ri ay tahay meesha ugu sarreysa ee wasakh kasta;iyo rs waa wadarta aagagga dhammaan meelaha ugu sarreeya: in aan ka badnayn 1.0% qof kasta oo wasakhaysan ayaa la helaa;oo aan ka badnayn 2.0% wadarta wasakhda la helay.
Imtixaan-
Marxaladda guurguura-diyaari xal ka kooban isku-dar biyo-ku-kulul n-butyl chloride, methylene chloride biyo-ku-kulul, glacial acetic acid, iyo tetrahydrofuran (350:125:15:10).Samee hagaajin haddii loo baahdo (eeg Habboonaanta Nidaamka ee hoos timaada Chromatography <621>).
Xalka heerka gudaha-Isticmaalka chloroform-ka biyaha-dherersan, diyaari xalka isoflupredone acetate oo ka kooban 0.04 mg halkii ml.
Diyaarinta caadiga ah-Mila tirada saxda ah ee USP Diflorasone Diacetate RS ee xalka gudaha si loo helo xal la og yahay oo ku saabsan 33µg halkii ml.
Diyaarinta Assay-Ku wareeji qiyaastii 15 mg ee Diflorasone Diacetate, oo si sax ah loo miisaamay, kuna wareeji caas mug leh oo 500-mL ah.Ku dar xalka heerka gudaha mugga, oo isku qas.
Nadaamka Chromatographic (eeg Chromatography <621>)-Kromaatograph-ka dareeraha ah waxa uu ku qalabaysan yahay 254-nm baaraha iyo tiir 4.6-mm × 10-cm ah oo ka kooban 3-µm xirmo L3.Heerka socodka waa qiyaastii 2.5 mL daqiiqadii.Chromatograph ee heerka diyaarinta, oo diwaangeli meelaha ugu sarreeya sida lagu faray Habka: xallinta, R, inta u dhaxaysa falanqaynta iyo heerka ugu sarreeya ee gudaha kama yara 12;iyo weecasho heerka qaraabo ee aan ka yarayn afar irbadood oo soo noqnoqda kama badna 2.0%.
Habka-Si gooni ah u duri mugga siman (qiyaastii 10 µL) ee diyaarinta Heerka iyo diyaarinta Assay chromatograph-ka, duub chromatogram-yada, oo cabbir aagagga meelaha ugu sarreeya.Wakhtiyada haynta qaraabo waa ilaa 1.0 diacetate diflorasone iyo 2.4 heerka gudaha.Xisaabi tirada, mg, ee C 26H32F2O7 ee qaybta Diflorasone Diacetate ee ay qaadatay qaacidada:
0.5C (RU / RS)
taas oo C ay tahay fiirsashada, µg halkii ml, ee USP Diflorasone Diacetate RS ee diyaarinta Heerka;iyo RU iyo RS waa saamiga meelaha ugu sarreeya ee Diflorasone Diacetate iyo aagagga heerka gudaha ee laga helay diyaarinta Assay iyo diyaarinta Heerka, siday u kala horreeyaan.