Polymyxin B Sulfate CAS 1405-20-5 Assay Microbiological ≥6500 IU/MG Factory

Polymyxin B, Sulfate.
Polymyxin B Sulfate [1405-20-5].
» Polymyxin B Sulfate shine gishirin sulfate na wani nau'in polymyxin, wani abu da ake samar da shi ta haɓakar Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae), ko cakuda irin wannan gishiri biyu ko fiye.Yana da ƙarfin da bai gaza 6000 Polymyxin B Units a kowace MG ba, ƙididdiga akan busasshen tushe.
Marufi da ajiya-Ajiye a cikin matsatsi, kwantena masu jure haske.
Lakabi-Inda aka shirya don hada magunguna, alamar ta bayyana adadin Polymyxin B Raka'a a cikin akwati da kowace milligram, cewa ba a yi nufin amfani da masana'anta ba, cewa ba bakararre ba ne, kuma ba za a iya tabbatar da ƙarfinsa fiye da 60 ba. kwanaki bayan budewa.Inda aka yi niyya don amfani da shi wajen shirya nau'ikan allura ko wasu bakararre, alamar ta bayyana cewa ba ta da lafiya ko kuma dole ne a ƙara sarrafa ta yayin shirye-shiryen alluran allura ko wasu nau'ikan alluran bakararre.
Matsayin Magana na USP <11>-
USP Polymyxin B Sulfate RS
Ganewa-
A: Liquid Chromatographic Identity Test-
Lokacin wayar hannu-Shirya cakuda 0.1 M tribasic sodium phosphate da acetonitrile (77:23), kuma daidaita tare da phosphoric acid zuwa pH na 3.0.Yi gyare-gyare idan ya cancanta (duba Dacewar Tsarin ƙarƙashin Chromatography <621>.
Daidaitaccen bayani-Shirya maganin USP Polymyxin B Sulfate RS a cikin Wayar hannu yana da taro kusan 3.5 MG kowace ml.Kare wannan bayani daga haske.
Maganin Gwaji-Shirya maganin Polymyxin B Sulfate a cikin Wayar hannu yana da kusantar 3.5 MG kowace ml.Kare wannan bayani daga haske.
Tsarin Chromatographic (duba Chromatography <621>) -Chromatograph na ruwa yana sanye da na'urar ganowa na 212-nm da ginshiƙin 4.6-mm × 25-cm wanda ya ƙunshi 5-µm tattara L1.Matsakaicin kwarara shine kusan 1 ml a minti daya.
Tsari-Na dabam allura daidai juzu'i (kimanin 10 µL) na daidaitaccen bayani da maganin Gwaji a cikin chromatograph, da yin rikodin chromatograms.chromatogram da aka samu daga maganin gwajin gwajin ya dace daidai da wanda aka samu daga daidaitaccen bayani, yana nuna babban kololuwa wanda ya dace da polymyxin B1 da kololuwa a lokutan riƙewa na kusan 0.5 (polymyxin B2) da 0.6 (polymyxin B3).
B: Narke 2 MG a cikin 5 ml na ruwa, ƙara 5 ml na 2.5 N sodium hydroxide, Mix, da kuma ƙara 5 saukad da na cupric sulfate bayani (1 a cikin 100), girgiza bayan da ƙari na kowane digo: an samar da launin ruwan violet. .
C: Magani (1 a cikin 20) ya dace da bukatun gwaje-gwaje don Sulfate <191>.
pH <791>: tsakanin 5.0 da 7.5, a cikin wani bayani dauke da 5 MG da ml.
Asarar bushewa <731> - bushe game da 100 MG, daidai a auna, a cikin kwalban da aka dakatar da capillary a cikin injin a cikin 60 ℃ na sa'o'i 3: ya rasa fiye da 7.0% na nauyinsa.
Abun ciki na phenylalanine-Canja wurin kusan 0.375 g na Polymyxin B Sulfate, daidai aunawa, zuwa flask ɗin volumetric 100-mL, narke a ciki kuma a tsoma shi da 0.1 N hydrochloric acid zuwa ƙara, da haɗuwa.Auna abin sha na wannan bayani a maxima a kusan 264 nm (A264), 258 nm (A258), da 252 nm (A252), da abubuwan sha a 280 nm (A280) da 300 nm (A300).Yi lissafin adadin phenylalanine a cikin ɓangaren Polymyxin B Sulfate wanda aka ɗauka ta dabara:
(9.4787/W)(A258 - 0.5A252 + 0.5A264 - 1.84A280 + 0.8A300)
wanda W shine nauyin nauyi, a g, na Polymyxin B Sulfate da aka ɗauka: ya ƙunshi tsakanin 9% da 12% na phenylalanine, ƙididdiga akan busassun tushe.
Sauran buƙatun- Idan don haɗawa da magani, ya cika buƙatun don Rago kan kunnawa a ƙarƙashin Polymyxin B don allura.Inda alamar ta bayyana cewa Polymyxin B Sulfate ba ta da lafiya, ta cika buƙatun don Gwajin Haihuwa <71> kuma, inda aka yi niyya don nau'ikan alluran allura, don Pyrogen ƙarƙashin Polymyxin B don allura.Inda alamar ta bayyana cewa Polymyxin B Sulfate dole ne a ƙaddamar da ƙarin aiki yayin shirye-shiryen nau'ikan alluran allura, ya cika buƙatun Pyrogen ƙarƙashin Polymyxin B don allura.
Assay-Ci gaba tare da Polymyxin B Sulfate kamar yadda aka umurce su a ƙarƙashin Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararrun Ƙwararru <81>.