Betamethasone CAS 378-44-9 Tsafta 97.0% ~ 103.0% API Babban Tsabta

Betamethasone
C22 H29FO5 392.46
Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17,21-trihydroxy-16-methyl-, (11,16) -.
9-Fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione [378-44-9].
Betamethasone ya ƙunshi bai wuce kashi 97.0 ba kuma bai wuce kashi 103.0 na C22H29FO5 ba, an ƙididdige shi akan busasshiyar tushe.
Marufi da ajiya-Ajiye a cikin matsuguni.Adana tsakanin 2 ℃ zuwa 30 ℃.
Matsayin Magana na USP <11>-
USP Betamethasone RS
Ganewa-
A: Ciwon Infrared <197M>.
B: Gwajin Ganewar Chromatographic Sirin-Layer <201>-
Maganin Gwaji-Shirya maganin Betamethasone a cikin barasa maras ruwa mai ɗauke da 0.5 MG kowace ml.
Haɓaka tsarin ƙarfi: cakuda chloroform da diethylamine (2: 1).
Tsari-ci gaba kamar yadda aka umurce a cikin babin, sai dai don gano wuraren ta hanyar fesa a hankali tare da dilute sulfuric acid (1 cikin 2) da dumama a farantin zafi ko ƙarƙashin fitila har sai tabo ya bayyana.
Takamaiman juyawa <781S>: tsakanin +118 da +126, ƙididdige su akan busasshiyar tushe.
Maganin gwaji: 5 MG kowace ml, a cikin methanol.
Asarar bushewa 731-Busar da shi a 105 na tsawon sa'o'i 3: bai wuce 1.0% na nauyinsa ba.
Ragowa akan ƙonewa 281: bai wuce 0.2% ba, ana amfani da crucible platinum.
Najasa na yau da kullun 466-
Maganin gwaji: methanol.
Daidaitaccen bayani: methanol.
Girman aikace-aikacen: 10 µL.
Eluant: cakuda toluene, acetone, methyl ethyl ketone, da formic acid (55:20:20:5), a cikin ɗakin da ba a daidaita ba.
Kallon gani: 5.
Assay-
Wayar hannu lokaci-Shirya wani tacewa da kuma gurɓataccen cakuda ruwa da acetonitrile (63:37).Yi gyare-gyare idan ya cancanta (duba Dacewar Tsarin ƙarƙashin Chromatography 621).
Maganin daidaitaccen ciki-Shirya maganin propylparaben a cikin barasa yana da sanannen taro na kusan 0.25 MG kowace ml.
Daidaitaccen shiri-Narkar da adadin USP Betamethasone RS daidai gwargwado a cikin barasa don samun maganin da yake da sananniya na kusan 0.2 MG kowace ml.Canja wurin 10.0 ml na wannan maganin zuwa vial mai dacewa, kuma ƙara 10.0 ml na daidaitaccen bayani na ciki, don samun daidaitaccen shiri wanda aka sani kusan 0.1 MG na betamethasone da kusan 0.125 MG na propylparaben kowace ml.
Shirye-shiryen Assay-Yin amfani da kusan 80 MG na Betamethasone, daidaitaccen awo, shirya kamar yadda aka umurce shi don daidaitaccen shiri.
Tsarin Chromatographic (duba Chromatography 621) -Cromatograph na ruwa yana sanye da na'urar ganowa 240-nm da ginshiƙi na 4.6-mm × 25-cm wanda ya ƙunshi tattara L1.Matsakaicin kwarara shine kusan 1.0 ml a minti daya.Chromatograph da Daidaitaccen shiri, da yin rikodin mafi girman martani kamar yadda aka ba da umarni don Tsari: lokutan riƙewa na dangi kusan 1.0 na betamethasone da 1.4 don propylparaben;ƙuduri, R, tsakanin betamethasone da propylparaben bai zama ƙasa da 3.0 ba;kuma madaidaicin ma'auni na dangi don kwafin injections bai wuce 2.0%.
Tsari-Na dabam allura daidai juzu'i (kimanin 10 µL) na daidaitaccen shiri da shirye-shiryen Assay a cikin chromatograph, yi rikodin chromatograms, da auna martani ga manyan kololuwa.Yi ƙididdige adadin, a cikin MG, na C22H29FO5 a cikin ɓangaren Betamethasone da aka ɗauka ta dabara:
800C (RU / RS)
wanda C shine maida hankali, a cikin MG da ml, na USP Betamethasone RS a cikin Shirye-shiryen Standard;da RU da RS sune madaidaitan tsayin tsayin betamethasone kololuwar ciki da aka samu daga shirye-shiryen Assay da Daidaitaccen shiri, bi da bi.