Polymyxin B Sulfate CAS 1405-20-5 Assay Microbiological ≥6500 IU/mg Factory
Shanghai Ruifu Chemical Co., Ltd jẹ olupilẹṣẹ asiwaju ati olupese ti Polymyxin B Sulfate (CAS: 1405-20-5) pẹlu didara to gaju.A le pese COA, ifijiṣẹ agbaye, kekere ati titobi pupọ ti o wa.Ti o ba nifẹ si Polymyxin B Sulfate,Please contact: alvin@ruifuchem.com
Orukọ Kemikali | Polymyxin B imi-ọjọ |
Awọn itumọ ọrọ sisọ | Polymyxin B Sulfate Iyọ;Aerosporin;Mastimyxin;PXNS;PMB;Poly-RX |
Iṣura Ipo | Ninu Iṣura, Agbara iṣelọpọ 10 Toonu fun Ọdun |
Nọmba CAS | 1405-20-5 |
Fọọmu Molecular | C55H96N16O13 · 2H2SO4 |
Òṣuwọn Molikula | 1301.56 |
Ojuami Iyo | 217.0 ~ 220.0 ℃ (oṣu kejila) |
Ni imọlara | Hygroscopic.Ifarabalẹ si Imọlẹ ati Ooru |
Omi Solubility | Tiotuka ninu Omi, 50 miligiramu / milimita.Tiotuka diẹ ni Ethanol |
COA & MSDS | Wa |
Apeere | Wa |
Brand | Ruifu Kemikali |
Awọn nkan | Awọn pato | Esi |
Ifarahan | Funfun tabi Fere Pẹlu Crystalline Powder | Ni ibamu |
Idanimọ A. Awọn akoko idaduro ti awọn oke pataki lati ojutu ayẹwo ni ibamu si awọn ti ojutu boṣewa, bi a ti gba ninu idanwo fun akopọ ti Polymyxins. | Ni ibamu | |
PH (2%) | 5.0 ~ 7.0 | 5.7 |
PH (0.5%) | 5.0 ~ 7.5 | 5.5 |
Sulfated Ash | ≤0.75% |
|
Yiyi pato [α] 20/D | -78.0°~-90.0°(C=2, H2O) (Calcd. lori Anh. Ohun elo) | -85.0° |
Sulfate | 15.5 ~ 17.5% | 16.65% |
Pipadanu lori Gbigbe | ≤6.00% | 3.0% |
Aloku lori Iginisonu | ≤0.10% | 0.02% |
Awọn irin Heavy | ≤20ppm | ≤20ppm |
Phenylalanine | 9.0 ~ 12.0% | 9.8% |
Lapapọ Viabel Aerobic kika | ≤10cfu/g | ≤10cfu/g |
Awọn nkan ti o jọmọ, HPLC |
|
|
Olukuluku Aimọ | ≤3.0% | 2.723% |
Lapapọ Awọn Aimọ | ≤17.0% | 16.223% |
Ayẹwo HPLC (ODB) | Apapọ Polymyxins B1, B2, B3 ati B1-1: ≥80.0% | 86.6% |
Polymyxin B3: ≤ 6.0% | 3.8% | |
Polymyxin B1-1: ≤15.0% | 8.5% | |
Ayẹwo, Microbiological (bi o ṣe jẹ) | ≥6500lU/mg | 8255IU/mg |
Patiku Iwon | ≥99.0% ≤30um nipasẹ vol | Ni ibamu |
≥90.0% ≤25um nipasẹ vol | ||
≥75.0%≤20um nipasẹ vol | ||
≥35.0%≤10um nipasẹ vol | ||
Ipari | Ọja naa ni ibamu pẹlu USP42 |
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Apo:Igo, apo apamọwọ Aluminiomu, 25kg / Paali Drum, tabi gẹgẹbi ibeere alabara.
Ipò Ìpamọ́:Imọlẹ imole.Jeki apo eiyan naa ni wiwọ ni pipade ati tọju ni itura, gbẹ (2 ~ 8℃) ati ile-itaja ti o ni afẹfẹ daradara kuro ninu awọn nkan ti ko ni ibamu.Dabobo lati ina ati ọrinrin.Ibamu pẹlu awọn aṣoju oxidizing lagbara.
Gbigbe:Firanṣẹ si agbaye nipasẹ afẹfẹ, nipasẹ FedEx / DHL Express.Pese ifijiṣẹ yarayara ati igbẹkẹle.
Bawo ni lati Ra?Jọwọ kan siDr. Alvin Huang: sales@ruifuchem.com or alvin@ruifuchem.com
15 Ọdun Iriri?A ni diẹ sii ju ọdun 15 ti iriri ni iṣelọpọ ati okeere ti ọpọlọpọ awọn agbedemeji elegbogi didara tabi awọn kemikali to dara.
Awọn ọja akọkọ?Ta si ọja ile, North America, Europe, India, Korea, Japanese, Australia, ati be be lo.
Awọn anfani?Didara to gaju, idiyele ifarada, awọn iṣẹ alamọdaju ati atilẹyin imọ-ẹrọ, ifijiṣẹ yarayara.
DidaraIdaniloju?Eto iṣakoso didara to muna.Awọn ohun elo ọjọgbọn fun itupalẹ pẹlu NMR, LC-MS, GC, HPLC, ICP-MS, UV, IR, OR, KF, ROI, LOD, MP, Clarity, Solubility, Microbial limit test, bbl
Awọn apẹẹrẹ?Pupọ awọn ọja pese awọn apẹẹrẹ ọfẹ fun igbelewọn didara, idiyele gbigbe yẹ ki o san nipasẹ awọn alabara.
Ayẹwo ile-iṣẹ?Ayẹwo ile-iṣẹ kaabo.Jọwọ ṣe ipinnu lati pade ni ilosiwaju.
MOQ?Ko si MOQ.Ibere kekere jẹ itẹwọgba.
Akoko Ifijiṣẹ? Ti o ba wa laarin ọja iṣura, iṣeduro ifijiṣẹ ọjọ mẹta.
Gbigbe?Nipa Express (FedEx, DHL), nipasẹ Air, nipasẹ Okun.
Awọn iwe aṣẹ?Lẹhin iṣẹ tita: COA, MOA, ROS, MSDS, ati bẹbẹ lọ ni a le pese.
Aṣa Synthesis?Le pese awọn iṣẹ iṣelọpọ aṣa lati baamu awọn iwulo iwadii rẹ dara julọ.
Awọn ofin sisan?Iwe risiti Proforma yoo firanṣẹ ni akọkọ lẹhin ijẹrisi aṣẹ, ti ifi alaye banki wa sinu.Isanwo nipasẹ T/T (Telex Gbigbe), PayPal, Western Union, ati bẹbẹ lọ.
Awọn aami ewu Xn - ipalara
Awọn koodu Ewu 22 - Ipalara ti o ba gbemi
Apejuwe Aabo S22 - Maṣe simi eruku.
S24/25 - Yago fun olubasọrọ pẹlu ara ati oju.
UN ID 3249
WGK Germany 3
RTECS TR1150000
FLUKA BRAND F CODES 3-8-10
HS koodu 2941909099
Ewu Kilasi 6.1(b)
Iṣakojọpọ Ẹgbẹ III
Polymyxin jẹ ẹgbẹ kan ti awọn egboogi polypeptide ti a ṣe nipasẹ Bacillus polymyxa (bacilluspolymyxa).Polymyxin B ati E ni a lo fun awọn idi oogun, ati pe awọn sulfates wọn jẹ lilo nigbagbogbo.Awọn ohun elo antibacterial ati awọn ohun elo iwosan ti Polymyxin B Sulfate jẹ iru awọn ti polymyxin E. O ni idinamọ tabi awọn ipa-ipa bactericidal lori gram-negative bacilli, gẹgẹbi Escherichia coli, Pseudomonas aeruginosa, paracilli, Klebsiella pneumoniae, acidophilus, pertussis ati Shigella.
Polymyxin Sulfate B jẹ iru si polymyxin e, ati pe o ni inhibitory tabi awọn ipa kokoro-arun lori bacilli gram-negative, gẹgẹbi e.coli, pseudomonas aeruginosa, paracilli, Klebsiella pneumoniae, acidophilus, bacilli pertussis ati dysentery bacilli.O ti wa ni o kun lo ninu egbo, ito ngba, oju, eti, trachea ati awọn miiran awọn ẹya ara ti ikolu ṣẹlẹ nipasẹ Pseudomonas aeruginosa ati awọn miiran Pseudomonas.O tun le ṣee lo fun sepsis ati peritonitis.Ati awọn akoran ti o lagbara ti o fa nipasẹ aminoglycosides, awọn kokoro arun cephalosporin ti iran-kẹta, Pseudomonas aeruginosa tabi awọn kokoro arun miiran ti o ni itara, gẹgẹbi bacteremia, endocarditis, pneumonia, ikolu lẹhin-iná, ati bẹbẹ lọ.
1. Ikọlẹ inu iṣan: awọn agbalagba ati awọn ọmọde pẹlu iṣẹ kidirin deede 1.5 ~ 2.5mg fun kilogram ti iwuwo ara (gbogbo kii ṣe ju 2.5mg fun kilogram ti iwuwo ara) fun ọjọ 1, pin si awọn akoko 2, drip lẹẹkan ni gbogbo wakati 12.Gbogbo 50mg ti ọja yii jẹ ti fomi pẹlu 500ml ti ojutu glukosi 5% ati lẹhinna ṣan silẹ.Awọn ọmọde ti o ni iṣẹ kidirin deede le fi aaye gba 4mg fun kilogram ti iwuwo ara fun ọjọ kan.2. Intramuscular injection: awọn agbalagba ati awọn ọmọde: 2.5 ~ 3mg fun kilogram ti iwuwo ara lori 1st, ti a fun ni awọn ipele, lẹẹkan ni gbogbo wakati 4 ~ 6.Awọn ọmọ ikoko le de ọdọ 4mg fun kilogram ti iwuwo ara fun ọjọ kan ati pe awọn ọmọ tuntun le de 4.5mg fun kilogram ti iwuwo ara.3. Intrathecal injection (fun Pseudomonas aeruginosa meningitis): 5mg fun milimita ti oogun omi ti a pese sile pẹlu abẹrẹ iṣuu soda kiloraidi.Awọn agbalagba ati awọn ọmọde ti o ju ọdun 2 lọ, 5mg lojoojumọ, lẹhin awọn ọjọ 3-4 ti ohun elo, yipada si ẹẹkan ni gbogbo ọjọ miiran, o kere ju ọsẹ 2, titi ti aṣa iṣan cerebrospinal jẹ odi, ati akoonu suga jẹ deede.Fun awọn ọmọde labẹ ọdun 2, lo 2mg lẹẹkan ni ọjọ kan fun 3-4 awọn ọjọ itẹlera (tabi 2.5mg lẹẹkan ni gbogbo ọjọ miiran), lẹhinna lo 2.5mg lẹẹkan ni gbogbo ọjọ miiran titi idanwo naa yoo jẹ deede.4. Awọn ifọkansi ti oju silė jẹ 1 ~ 2.5mg fun milimita.
Yago fun apapọ pẹlu awọn oogun ti o ba awọn kidinrin jẹ, awọn isinmi ti iṣan ti iṣan, awọn egboogi aminoglycoside, anesthetics pẹlu awọn ipa isinmi iṣan ti o han gbangba (gẹgẹbi enflurane), ati bẹbẹ lọ, ati quinine, iṣuu magnẹsia, ati bẹbẹ lọ ko ṣee lo ni iṣan ni akoko kanna.Polymyxin B sulfate ti wa ni idapo pelu sulfonamides, rifampicin, ologbele-synthetic penicillin, ati bẹbẹ lọ, fun itọju ti awọn akoran kokoro-arun gram-negative ti oogun ti o lagbara, ati pe ipa naa dara ju ti ohun elo ẹyọkan lọ.
1, Awọn aboyun ati awọn obinrin ti o nmu ọmu, awọn ọmọde, ati awọn alaisan ti o ni ailagbara kidirin ti o lagbara ni o wọpọ julọ.2. Ọja yii jẹ majele ti o ga ati pe ko ni ipa alumoni lori ikolu ti àsopọ jinlẹ.Kii ṣe yiyan akọkọ fun eyikeyi ikolu.3. Abẹrẹ inu iṣan le fa ibanujẹ atẹgun, eyiti a ko lo ni gbogbogbo.O kere ju idaji iwọn lilo ojoojumọ nilo ṣiṣan iṣan iṣan, kii ṣe bolus iyara ni ẹẹkan, lati yago fun bulọọki neuromuscular pupọ.4. Ko yẹ ki o ni idapo pẹlu awọn oogun miiran pẹlu nephrotoxicity tabi neuromuscular blockade lati yago fun awọn ijamba.
Iwadi biokemika.Polymyxin B jẹ egboogi-gram-negative bacilli polypeptide aporo, eyi ti o le yi awọn awo awo ara lati jo kekere moleku ati idilọwọ awọn idagba ti giramu-odi kokoro arun.O ni ipa bactericidal lori Escherichia coli.Awọn ohun elo Lipid A ti a so mọ lipopolysaccharides kokoro arun.Awọn pores kekere ni a fa ni awọ ara ita ti awọ ara.Ipo iṣe: sopọ ati dabaru pẹlu ailagbara ti awọ ara cytoplasmic.Apakan spekitira: Giramu-odi kokoro arun.
Polymyxin B, Sulfate.
Polymyxin B Sulfate [1405-20-5].
»Polymyxin B Sulfate jẹ iyọ sulfate ti iru polymyxin kan, nkan ti o ṣe nipasẹ idagba ti Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae), tabi adalu meji tabi diẹ ẹ sii iru awọn iyọ.O ni agbara ti ko din ju 6000 Polymyxin B Units fun miligiramu, ti a ṣe iṣiro lori ipilẹ ti o gbẹ.
Iṣakojọpọ ati ibi ipamọ-Fipamọ sinu wiwọ, awọn apoti sooro ina.
Aami-Nibi ti a ti ṣajọpọ fun iṣakojọpọ oogun, aami naa sọ nọmba ti Polymyxin B Units ninu apo ati fun miligiramu kan, pe kii ṣe ipinnu fun lilo iṣelọpọ, pe ko jẹ aibikita, ati pe agbara rẹ ko le ṣe idaniloju fun gun ju 60 lọ. awọn ọjọ lẹhin ṣiṣi.Nibiti o ti pinnu fun lilo ni igbaradi injectable tabi awọn fọọmu iwọn lilo ifo miiran, aami naa sọ pe o jẹ aibikita tabi o gbọdọ wa labẹ sisẹ siwaju sii lakoko igbaradi ti injectable tabi awọn fọọmu iwọn lilo ifo miiran.
Awọn ajohunše Itọkasi USP <11>-
USP Polymyxin B Sulfate RS
Idanimọ-
A: Idanwo idanimọ Chromatographic Liquid-
Alagbeka alakoso-Mura adalu 0.1 M tribasic sodium phosphate ati acetonitrile (77:23), ki o si ṣatunṣe pẹlu phosphoric acid si pH ti 3.0.Ṣe awọn atunṣe ti o ba jẹ dandan (wo Ibaramu Eto labẹ Chromatography <621>.
Ojutu boṣewa-Mura ojutu kan ti USP Polymyxin B Sulfate RS ni apakan Alagbeka nini ifọkansi ti iwọn 3.5 miligiramu fun milimita kan.Dabobo ojutu yii lati ina.
Idanwo ojutu-Mura ojutu kan ti Polymyxin B Sulfate ni Alagbeka alakoso nini ifọkansi ti o to 3.5 miligiramu fun milimita kan.Dabobo ojutu yii lati ina.
Eto Chromatographic (wo Chromatography <621>)) -Kromatograph olomi ti ni ipese pẹlu aṣawari 212-nm ati iwe 4.6-mm × 25-cm ti o ni iṣakojọpọ 5-µm L1.Iwọn sisan jẹ nipa 1 milimita fun iṣẹju kan.
Ilana-lọtọ itọ awọn iwọn didun dogba (nipa 10 µL) ti ojutu Standard ati ojutu idanwo sinu chromatograph, ati ṣe igbasilẹ awọn chromatograms.Kromatogram ti a gba lati inu ojutu Idanwo ni ibamu pẹlu agbara si eyiti o gba lati ojutu Standard, ti n ṣafihan tente oke pataki kan ti o baamu polymyxin B1 ati awọn oke ni awọn akoko idaduro ibatan ti 0.5 (polymyxin B2) ati 0.6 (polymyxin B3).
B: Tu 2 iwon miligiramu ni 5 milimita ti omi, fi 5 milimita ti 2.5 N sodium hydroxide, dapọ, ki o si fi 5 silė ti ojutu sulfate cupric (1 ni 100), gbigbọn lẹhin afikun ti kọọkan silẹ: awọ violet pupa ti wa ni iṣelọpọ. .
C: Ojutu kan (1 ni 20) pade awọn ibeere ti awọn idanwo fun Sulfate <191>.
pH <791>: laarin 5.0 ati 7.5, ninu ojutu ti o ni 5 miligiramu fun milimita kan.
Pipadanu lori gbigbe <731>-Gbẹ nipa 100 miligiramu, ni iwọn deede, ninu igo ti o duro ni capillary ni igbale ni 60℃ fun wakati 3: ko padanu diẹ sii ju 7.0% ti iwuwo rẹ.
Akoonu ti phenylalanine-Gbigbe lọ si nkan bi 0.375 g ti Polymyxin B Sulfate, ti wọn ni deede, si 100-mL volumetric flask, tu sinu ati dilute pẹlu 0.1 N hydrochloric acid si iwọn didun, ati dapọ.Ṣe iwọn awọn ifunmọ ti ojutu yii ni maxima ni iwọn 264 nm (A264), 258 nm (A258), ati 252 nm (A252), ati awọn gbigba ni 280 nm (A280) ati 300 nm (A300).Ṣe iṣiro ipin phenylalanine ni ipin ti Polymyxin B Sulfate ti o mu nipasẹ agbekalẹ:
(9.4787/W)(A258 – 0.5A252 + 0.5A264 – 1.84A280 + 0.8A300)
ninu eyiti W jẹ iwuwo, ni g, ti Polymyxin B Sulfate ti o mu: o ni laarin 9% ati 12% ti phenylalanine, ti a ṣe iṣiro lori ipilẹ ti o gbẹ.
Awọn ibeere miiran- Ti o ba jẹ idapọmọra ogun, o pade awọn ibeere fun Residue lori ignition labẹ Polymyxin B fun Abẹrẹ.Nibo ti aami naa ti sọ pe Polymyxin B Sulfate jẹ aibikita, o pade awọn ibeere fun Awọn idanwo Ailesabiyamo <71> ati, nibiti a ti pinnu fun awọn fọọmu iwọn lilo injectable, fun Pyrogen labẹ Polymyxin B fun Abẹrẹ.Nibiti aami naa ti sọ pe Polymyxin B Sulfate gbọdọ wa ni labẹ sisẹ siwaju lakoko igbaradi ti awọn fọọmu iwọn lilo injectable, o pade awọn ibeere fun Pyrogen labẹ Polymyxin B fun Abẹrẹ.
Igbeyewo-Tẹsiwaju pẹlu Polymyxin B Sulfate gẹgẹbi a ti ṣe itọsọna labẹ Awọn Aṣeyẹwo Awọn Agbogun-Microbial <81>.