Polymyxin B Sulfate CAS 1405-20-5 Assay Microbiological ≥6500 IU/mg Ụlọ ọrụ

Polymyxin B, sulfate.
Polymyxin B Sulfate [1405-20-5].
» Polymyxin B Sulfate bụ nnu sulfate nke ụdị polymyxin, ihe na-emepụta site na uto Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae), ma ọ bụ ngwakọta nke nnu abụọ ma ọ bụ karịa.Ọ nwere ikike nke na-erughị 6000 Polymyxin B Units kwa mg, gbakọọ na ntọala akpọnwụwo.
Nkwakọ ngwaahịa na nchekwa - Chekwaa n'ime akpa siri ike, enweghị ọkụ.
Labeling-Ebe a na-etinye ya maka nchịkọta ndenye ọgwụ, akara ahụ na-ekwu ọnụ ọgụgụ nke Polymyxin B Units n'ime akpa na kwa milligram, na ọ bụghị maka mmepụta ihe, na ọ bụghị nke ọma, na enweghị ike ijide n'aka na ike ya karịrị 60. ụbọchị mgbe emepechara.N'ebe e bu n'obi kee ya n'ịkwadebe ụdị ọgwụgwọ injectable ma ọ bụ ihe ndị ọzọ na-adịghị mma, akara ahụ na-ekwu na ọ bụ ihe na-adịghị mma ma ọ bụ na a ga-edozi ya n'ihu nhazi n'oge nkwadebe nke injectable ma ọ bụ ụdị usoro onunu ogwu ndị ọzọ.
Ụkpụrụ ntụaka USP <11>-
USP Polymyxin B Sulfate RS
njirimara-
A: Nnwale njirimara Chromatographic Liquid-
Usoro mkpanaaka - Kwadebe ngwakọta nke 0.1 M tribasic sodium phosphate na acetonitrile (77:23), ma dozie ya na phosphoric acid ka ọ bụrụ pH nke 3.0.Mee mgbanwe ma ọ dị mkpa (lee Dabara Sistemu n'okpuru Chromatography <621>.
Ọkọlọtọ ngwọta- Kwadebe ihe ngwọta nke USP Polymyxin B Sulfate RS na usoro mkpanaaka na-enwe mkpokọta ihe dịka 3.5 mg kwa ml.Chebe ngwọta a site na ìhè.
Ngwọta nnwale- Kwadebe ihe ngwọta nke Polymyxin B Sulfate na usoro mkpanaaka na-enwe mkpokọta ihe dịka 3.5 mg kwa ml.Chebe ngwọta a site na ìhè.
Usoro Chromatographic (lee Chromatography <621>) -Kromatograph mmiri mmiri nwere ihe nchọta 212-nm yana kọlụm 4.6mm × 25-cm nke nwere 5-µm mbukota L1.Ọnụego mmiri ahụ bụ ihe dịka 1 ml kwa nkeji.
Usoro-iche iche, gbanye nha nha nha nha (ihe dịka 10 µL) nke ọkọlọtọ ọkọlọtọ na ngwọta nnwale n'ime chromatograph, wee dekọọ chromatograms.Chromatogram enwetara site na Ngwọta Nnwale dabara nke ọma na nke enwetara site na ngwọta Standard, na-egosipụta nnukwu ọnụ ọgụgụ dị elu kwekọrọ na polymyxin B1 na ọnụ ọgụgụ kacha elu n'oge njigide nke ihe dịka 0.5 (polymyxin B2) na 0.6 (polymyxin B3).
B: igbari 2 mg na 5 mL mmiri, tinye 5 ml nke 2.5 N sodium hydroxide, mix, na tinye 5 tụlee nke cupric sulfate ngwọta (1 na 100), na-ama jijiji mgbe mgbakwunye nke ọ bụla dobe: a na-acha ọbara ọbara violet agba. .
C: A ngwọta (1 na 20) na-ezute ihe ndị a chọrọ nke ule maka Sulfate <191>.
pH <791>: n'etiti 5.0 na 7.5, na ngwọta nwere 5 mg kwa ml.
Ọnwụ na ihicha <731>-akọrọ ihe dịka 100 mg, tụọ ya nke ọma, na karama capillary-stoppered na oghere na 60 ℃ maka awa 3: ọ na-efunahụ ihe karịrị 7.0% nke ibu ya.
Ọdịnaya nke phenylalanine- Nyefee ihe dịka 0.375 g nke Polymyxin B Sulfate, nke a tụrụ nke ọma, gaa na flask volumetric 100-mL, gbazee na 0.1 N hydrochloric acid ka ọ bụrụ olu, ma gwakọta ya.Tụọ ihe ntinye nke ngwọta a na maxima na ihe dịka 264 nm (A264), 258 nm (A258), na 252 nm (A252), na ihe ndị ahụ na 280 nm (A280) na 300 nm (A300).Gbakọọ pasent nke phenylalanine na akụkụ nke Polymyxin B Sulfate nke usoro a were were:
(9.4787/W)(A258 – 0.5A252 + 0.5A264 – 1.84A280 + 0.8A300)
nke W dị arọ, na g, nke Polymyxin B Sulfate weere: ọ nwere n'etiti 9% na 12% nke phenylalanine, gbakọọ na ntọala a mịrị amị.
Ihe ndị ọzọ a chọrọ - Ọ bụrụ maka nchịkọta ndenye ọgwụ, ọ na-emezu ihe achọrọ maka Residue na mgbanye n'okpuru Polymyxin B maka injection.Ebe akara na-ekwu na Polymyxin B Sulfate bụ sterile, ọ na-emezu ihe achọrọ maka ule Sterility <71> na, ebe ezubere maka ụdị usoro onunu ogwu, maka Pyrogen n'okpuru Polymyxin B maka ịgba ọgwụ.Ebe akara ahụ na-ekwu na Polymyxin B Sulfate ga-enwerịrị nhazi ọzọ n'oge nkwadebe nke ụdị usoro onunu ogwu, ọ na-emezu ihe achọrọ maka Pyrogen n'okpuru Polymyxin B maka injection.
Nyocha-Gaa n'ihu na Polymyxin B Sulfate dị ka eduzi n'okpuru Antibiotics-Microbial Assays <81>.