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

I-Diflorasone Diacetate [33564-31-7]
» I-Diflorasone Diacetate iqukethe amaphesenti angekho ngaphansi kwamaphesenti angu-97.0 futhi angabi ngaphezu kwamaphesenti angu-103.0 we-C26H32F2O7, abalwe ngokomisiwe.
Ukupakisha nokugcina-Londoloza ezitsheni eziqinile.
Amazinga ereferensi we-USP <11>-
I-USP Diflorasone Diacetate RS
Ukuhlonza, Ukumuncwa kwe-Infrared <197M>.
Ukuzungezisa okuqondile <781S>: phakathi kuka-+58° no-+68°.Isixazululo sokuhlola: 20 mg, esomisiwe, ngemL ngayinye, ku-chloroform.
Ukulahlekelwa ekumisweni <731> -Yomise ku-vacuum ku-60 ° futhi ngengcindezi engeqile ku-5 mm ye-mer cury amahora angu-16: ilahlekelwa ngaphezu kuka-0.5% wesisindo sayo.
Izinsalela ekushiseni <281>: hhayi ngaphezu kuka-0.5%
Ubumsulwa beChromatographic-
Isigaba seselula nohlelo lwe-Chromatographic-Lungiselela njengoba kuqondiswe ku-Assay.
Isixazululo sokuhlola-Chaza inani elinembile lesisindo se-Diflorasone Diacetate ku-chloroform egcwele amanzi ukuze uthole isixazululo esinokugxila okungaba ngu-6 mg nge-mL ngayinye.
Inqubo-Jonga ivolumu (cishe u-10 µL) wesixazululo Sokuhlola ku-chromatograph, rekhoda i-chromatogram isikhathi esilingana nezikhathi ezi-5 zesikhathi sokugcina sokuphakama okukhulu, bese ukala izindawo zazo zonke iziqongo.Bala iphesenti lokungcola ngakunye engxenyeni ye-Diflorasone Diacetate ethathwe ifomula:
100(ri/rs)
lapho i-ri iyindawo ephakeme kakhulu yokungcola ngakunye;futhi u-rs uyisamba sezindawo zazo zonke iziqongo: akutholakali ngaphezu kuka-1.0% wanoma yikuphi ukungcola okukodwa;futhi akukho ngaphezu kuka-2.0% wokungcola okuphelele okutholakele.
Isivivinyo-
Isigaba seselula-Lungiselela isixazululo esiqukethe ingxube ye-n-butyl chloride egcwele amanzi, i-methylene chloride egcwele amanzi, i-glacial acetic acid, ne-tetrahydrofuran (350:125:15:10).Yenza izinguquko uma kudingeka (bona Ukufaneleka Kwesistimu ngaphansi kwe-Chromatography <621>).
Isixazululo esijwayelekile sangaphakathi-Usebenzisa i-chloroform egcwele amanzi, lungiselela isisombululo se-isoflupredone acetate equkethe cishe u-0.04 mg ngemL ngayinye.
Ukulungiselela okujwayelekile-Chaza isamba esikalwe ngokunembile se-USP Diflorasone Diacetate RS kusixazululo esijwayelekile sangaphakathi ukuze uthole isixazululo esinokugxila okwaziwayo okungaba ngu-33µg ngemL ngayinye.
Ukulungiselela i-assay-Dlulisa cishe u-15 mg we-Diflorasone Diacetate, ukalwe ngokunembile, uye kuflask yevolumu ye-500-mL.Engeza isisombululo esijwayelekile sangaphakathi kuvolumu, bese uxuba.
Isistimu ye-Chromatographic (bona i-Chromatography <621>)-I-chromatograph ewuketshezi ifakwe umtshina ongu-254-nm kanye nekholomu engu-4.6-mm × 10-cm equkethe 3- µm ukupakisha L3.Izinga lokugeleza licishe libe ngu-2.5 mL ngomzuzu.I-Chromatograph ukulungiselelwa Okujwayelekile, futhi irekhode izindawo eziphakeme njengoba kuqondiswe kuNqubo: ukulungiswa, R, phakathi kohlaziyo neziqongo ezijwayelekile zangaphakathi akukhona ngaphansi kuka-12;futhi ukuchezuka okujwayelekile okuhlobene kwemijovo ephindaphindayo engekho ngaphansi kwezine akukho ngaphezu kuka-2.0%.
Inqubo-Ngokuhlukile jova amavolumu alinganayo (cishe u-10 µL) wokulungiselelwa Okujwayelekile kanye nokulungiswa kwe-Assay ku-chromatograph, rekhoda ama-chromatogram, futhi ulinganise izindawo zeziqongo ezinkulu.Izikhathi zokugcinwa okuhlobene zicishe zibe ngu-1.0 ze-diflorasone diacetate kanye no-2.4 ngokwezinga langaphakathi.Bala inani, ngo-mg, le-C 26H32F2O7 engxenyeni ye-Diflorasone Diacetate ethathwe ifomula:
0.5C(RU / RS)
lapho u-C eyingqikithi, ku-µg ngemL, ye-USP Diflorasone Diacetate RS ekulungiseleleni Okujwayelekile;kanye ne-RU kanye ne-RS izilinganiso zezindawo eziphakeme kakhulu ze-Diflorasone Diacetate kanye nezindawo ezijwayelekile zangaphakathi ezitholwe ekulungiselelweni kwe-Assay nasekulungiseleleni Okujwayelekile, ngokulandelanayo.