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

Diflorasone Diacetate [33564-31-7]
» Diflorasone Diacetate muaj tsis pub tsawg dua 97.0 feem pua ​​thiab tsis ntau tshaj 103.0 feem pua ​​ntawm C26H32F2O7, xam rau ntawm qhuav hauv paus.
Ntim thiab khaws cia-Txuag hauv cov thawv nruj.
USP Reference cov qauv <11>-
USP Diflorasone Diacetate RS
Kev txheeb xyuas, Infrared Absorption <197M>.
Kev sib hloov tshwj xeeb <781S>: ntawm +58 ° thiab +68 °.Kev tshuaj ntsuam xyuas: 20 mg, undried, ib mL, hauv chloroform.
Poob ntawm ziab <731>-Sry nws hauv lub tshuab nqus tsev ntawm 60 ° thiab ntawm qhov siab tsis tshaj 5 hli ntawm mer cury rau 16 teev: nws poob tsis ntau tshaj 0.5% ntawm nws qhov hnyav.
Residue ntawm ignition <281>: tsis ntau tshaj 0.5%
Chromatographic purity-
Mobile theem thiab Chromatographic system-Npaj raws li qhia hauv Assay.
Test solution-Dissolve ib qho hnyav hnyav ntawm Diflorasone Diacetate hauv dej-saturated chloroform kom tau txais cov tshuaj uas muaj qhov concentration ntawm li 6 mg ib mL.
Cov txheej txheem-Txhim ib lub ntim (kwv yees li 10 µL) ntawm cov tshuaj Test rau hauv chromatograph, sau cov chromatogram rau ib lub sij hawm sib npaug li 5 npaug ntawm lub sij hawm tuav ntawm lub ncov loj, thiab ntsuas qhov chaw ntawm tag nrho cov ncov.Xam cov feem pua ​​​​ntawm txhua qhov impurity hauv feem ntawm Diflorasone Diacetate coj los ntawm cov mis:
100 (ri / rs)
nyob rau hauv uas ri yog lub ncov cheeb tsam rau txhua impurity;thiab rs yog qhov sib npaug ntawm thaj chaw ntawm tag nrho cov ncov: tsis pub ntau tshaj 1.0% ntawm ib tus neeg tsis huv yog pom;thiab tsis pub ntau tshaj 2.0% ntawm tag nrho cov impurities pom.
Assay-
Txawb theem- Npaj cov tshuaj uas muaj cov dej-saturated n-butyl chloride, dej-saturated methylene chloride, glacial acetic acid, thiab tetrahydrofuran (350:125:15:10).Ua kev hloov kho yog tias tsim nyog (saib System Suitability hauv Chromatography <621>).
Cov txheej txheem sab hauv-Siv dej-saturated chloroform, npaj cov tshuaj isoflupredone acetate uas muaj txog 0.04 mg ib mL.
Cov txheej txheem kev npaj-Dissolve ib qho hnyav hnyav ntawm USP Diflorasone Diacetate RS nyob rau hauv cov txheej txheem kev daws teeb meem kom tau txais cov kev daws teeb meem uas paub txog qhov concentration ntawm 33µg ib mL.
Kev tshuaj ntsuam xyuas-Hloov txog 15 mg ntawm Diflorasone Diacetate, ntsuas kom raug, mus rau 500-mL ntim ntim.Ntxiv Internal standard tov rau ntim, thiab sib tov.
Chromatographic system (saib Chromatography <621>)-Cov kua chromatograph yog nruab nrog 254-nm detector thiab 4.6-mm × 10-cm kem uas muaj 3- µm packing L3.Tus nqi ntws yog li 2.5 mL ib feeb.Chromatograph tus qauv npaj, thiab sau cov cheeb tsam ncov raws li qhia rau txheej txheem: kev daws teeb meem, R, nruab nrab ntawm cov ntsuas ntsuas thiab cov txheej txheem sab hauv tsis tsawg dua 12;thiab tus txheeb ze tus qauv sib txawv rau tsis pub tsawg tshaj plaub qhov kev txhaj tshuaj replicate tsis ntau tshaj 2.0%.
Cov txheej txheem-Kev txhaj tshuaj sib npaug (kwv yees li 10 µL) ntawm Standard npaj thiab Assay npaj rau hauv chromatograph, sau cov chromatograms, thiab ntsuas qhov chaw rau lub ncov loj.Lub sij hawm tuav tus txheeb ze yog kwv yees li 1.0 rau diflorasone diacetate thiab 2.4 rau tus qauv sab hauv.Xam qhov ntau, hauv mg, ntawm C 26H32F2O7 hauv feem ntawm Diflorasone Diacetate coj los ntawm cov mis:
0.5C (RU / RS)
nyob rau hauv uas C yog qhov concentration, nyob rau hauv µg ib mL, ntawm USP Diflorasone Diacetate RS nyob rau hauv tus txheej txheem npaj;thiab RU thiab RS yog qhov sib piv ntawm thaj chaw ncov rau Diflorasone Diacetate thiab cov txheej txheem sab hauv tau txais los ntawm Assay npaj thiab Standard npaj, feem.