Rivastigmine Tartrate CAS 129101-54-8 Assay 98.0 ~ 102.0
Shanghai Ruifu Chemical Co., Ltd jẹ olupilẹṣẹ asiwaju ti Rivastigmine Tartrate (CAS: 129101-54-8) pẹlu didara to gaju.Kemikali Ruifu le pese ifijiṣẹ agbaye, idiyele ifigagbaga, iṣẹ ti o dara julọ, kekere ati awọn iwọn olopobobo ti o wa.Ra Rivastigmine Tartrate,Please contact: alvin@ruifuchem.com
| Orukọ Kemikali | Rivastigmine Tartrate |
| Awọn itumọ ọrọ sisọ | Exelon;ENA-713;Rivastigmine L-Tartrate;Rivastigmine Hydrogen Tartrate;CS-118;S-Rivastigmine Tartrate;3- [(S) -1- (Dimethylamino) ethyl] phenyl N-Ethyl-N-Methylcarbamate L-Tartrate;N-Ethyl-N-Methylcarbamic Acid 3-[(S)-1- (Dimethylamino) ethyl] phenyl Ester L-Tartrate |
| Iṣura Ipo | Ni Iṣura, Iṣowo Iṣowo |
| Nọmba CAS | 129101-54-8 |
| CAS ti o ni ibatan | 123441-03-2 |
| Fọọmu Molecular | C14H22N2O2 · C4H6O6 |
| Òṣuwọn Molikula | 400,43 g / mol |
| Ojuami Iyo | 124.0 si 128.0 ℃ |
| Yiyi pato [a] 20/D | +4.0° si +7.0° (C=5, kẹmika kẹmika) |
| Solubility | Tiotuka ni kẹmika |
| COA & MSDS | Wa |
| Ipilẹṣẹ | Shanghai, China |
| Brand | Ruifu Kemikali |
| Awọn nkan | Ayewo Standards | Esi |
| Ifarahan | Funfun lati Pa-White Crystalline Powder | Ibamu |
| Ayẹwo | 98.0 ~ 102.0% (lori ipilẹ Anhydrous) | 99.8% |
| Omi nipa Karl Fischer | ≤0.50% | 0.15% |
| Aloku lori Iginisonu | ≤0.10% | 0.07% |
| Awọn Irin Eru (Pb) | ≤20ppm | <10ppm |
| Phenol aimọ | ≤0.30% | <0.30% |
| DPTTA | ≤0.15% | <0.15% |
| Tabi Aimọ | ≤0.15% | <0.15% |
| Carbamate aimọ | ≤0.15% | <0.15% |
| Eteri aimọ | ≤0.15% | <0.15% |
| Eyikeyi Iwa Aimọ | ≤0.10% | <0.10% |
| Lapapọ awọn idoti | ≤0.50% | <0.50% |
| R-Enantiomer | ≤0.30% | <0.30% |
| Infurarẹẹdi julọ.Oniranran | Ni ibamu pẹlu Eto | Ibamu |
| 1H NMR julọ.Oniranran | Ni ibamu pẹlu Eto | Ibamu |
| Ipari | Ọja naa ti ni idanwo ati ni ibamu pẹlu Standard USP35 | |
Apo:Igo Fluorinated, apo apamọwọ Aluminiomu, 25kg / Paali Drum, tabi gẹgẹbi ibeere alabara.
Ipò Ìpamọ́: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.
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Rivastigmine Tartrate
C14H22N2O2 · C4H6O6 400.42
Ethylmethylcarbamic acid, 3-[(S) -1- (dimethylamino) ethyl] phenyl ester, (2R, 3R) -2,3-dihydroxybutanedioate;
(S) -3- [1- (Dimethylamino) ethyl] phenyl ethylmethylcarbamate, hydrogen tartrate [129101-54-8].
Rivastigmine 250.34 [123441-03-2].
ITUMO
Rivastigmine Tartrate ni NLT 98.0% ati NMT 102.0% ti iye aami ti C14H22N2O2 · C4H6O6, iṣiro lori ipilẹ anhydrous.
Ìdámọ̀
• A. Gbigba infurarẹẹdi <197K>
• B. Awọn akoko idaduro ti awọn pataki tente oke ti awọn Ayẹwo ojutu ni ibamu si awọn ti awọn System ìbójúmu ojutu, bi gba ninu igbeyewo fun Organic impurities, Ilana 2: Enantiomeric Purity.
ASAY
• Ilana
Idaduro: 8.6 mg/ml ti fosifeti monobasic ammonium.Ṣatunṣe pẹlu ojutu amonia si pH ti 7.0.
Ipele alagbeka: kẹmika, acetonitrile, ati Buffer (15:15:70)
Ojutu ìbójúmu eto: 0.05 mg/mL kọọkan ti USP Rivastigmine Jẹmọ Compound A RS ati USP Rivastigmine ibatan Compound B RS ni Mobile alakoso
Ojutu boṣewa: 0.2 mg/mL ti USP Rivastigmine Tartrate RS ni apakan Alagbeka
Ojutu ayẹwo: 0.2 mg/mL ti Rivastigmine Tartrate ni apakan Alagbeka
Eto Chromatographic
(Wo Chromatography <621>, Ibamu Eto.)
Ipo: LC
Oluwadi: UV 215 nm
Ọwọn: 4.6-mm × 25-cm;5-µm iṣakojọpọ L7
Oṣuwọn sisan: 1.2 milimita / min
Iwọn abẹrẹ: 20µL
[Akiyesi-Oṣuwọn sisan le ṣe atunṣe si 1.5 mL/min, ti o ba nilo, lati ṣaṣeyọri akoko idaduro iṣeduro ti rivastigmine ni bii 10 min.]
Ibamu eto
Awọn apẹẹrẹ: Ojutu ibamu eto ati ojutu Standard
Awọn ibeere ibamu
Ipinnu: NLT 1.5 laarin rivastigmine ti o ni ibatan yellow A ati rivastigmine ti o ni ibatan agbo B, ojutu ibamu eto
Iṣaṣe ti ọwọn: NLT 5000 awọn apẹrẹ imọ-jinlẹ, ojutu Standard
Tailing ifosiwewe: NMT 3.0, Standard ojutu
Ojulumo boṣewa iyapa: NMT 2.0%, Standard ojutu
Onínọmbà
Awọn apẹẹrẹ: Ojutu boṣewa ati ojutu Ayẹwo
Ṣe iṣiro ipin ti C14H22N2O2 · C4H6O6 ni apakan Rivastigmine Tartrate ti o mu:
Esi = (rU/rS) × (CS/CU) × 100
rU = idahun ti o ga julọ lati inu ojutu Ayẹwo
rS = idahun ti o ga julọ lati ojutu Standard
CS = ifọkansi ti ojutu Standard (mg/mL)
CU = ifọkansi ti ojutu Ayẹwo (mg/mL)
Awọn ibeere gbigba: 98.0% -102.0% lori ipilẹ anhydrous
ALÁÌṢẸ́
Awọn Egbin Aiṣedeede
Aloku lori Iginisonu <281>: NMT 0.1%
• Awọn irin Heavy, Ọna II <231>: NMT 20 ppm
Organic impurities
• Ilana 1
Alakoso Alagbeka ati ojutu ibaramu Eto: Tẹsiwaju bi a ti ṣe itọsọna ninu Assay.
Ojutu boṣewa: 1.0 µg/ml ti USP Rivastigmine Tartrate RS ni ipele Alagbeka
Ojutu ayẹwo: 1.0 mg/mL ti Rivastigmine Tartrate ni apakan Alagbeka
Eto Chromatographic: Tẹsiwaju bi a ti ṣe itọsọna ninu Assay.
(Wo Chromatography <621>, Ibamu Eto.)
Ibamu eto
Awọn apẹẹrẹ: Ojutu ibamu eto ati ojutu Standard
Awọn ibeere ibamu
Ipinnu: NLT 1.5 laarin rivastigmine ti o ni ibatan yellow A ati rivastigmine ti o ni ibatan agbo B, ojutu ibamu eto
Ojulumo boṣewa iyapa: NMT 10%, Standard ojutu
Onínọmbà [Akiyesi-Akoko ṣiṣe jẹ awọn akoko 8 akoko idaduro ti tente oke rivastigmine.]
Awọn apẹẹrẹ: Ojutu boṣewa ati ojutu Ayẹwo
Ṣe iṣiro ipin ogorun aimọ kọọkan kọọkan ni apakan Rivastigmine Tartrate ti o mu:
Esi = (rU/rS) × (CS/CU) × (1/F) × 100
rU = idahun ti o ga julọ fun aimọ kọọkan lati inu ojutu Ayẹwo
rS = idahun ti o ga julọ lati ojutu Standard
CS = ifọkansi ti USP Rivastigmine Tartrate RS ninu ojutu Standard (mg/mL)
CU = ifọkansi ti Rivastigmine Tartrate ninu ojutu Ayẹwo (mg/mL)
F = ifosiwewe idahun ojulumo (wo Tabili Aimọ 1)
Awọn ilana gbigba
Awọn aimọ ẹnikọọkan: Wo Tabili Aimọ 1.
Lapapọ awọn aimọ: NMT 0.5%
Tabili àìmọ́ 1
| Oruko | Ojulumo Idaduro Time | Ojulumo Idahun ifosiwewe | Ilana gbigba NMT % |
| Tartrate | 0.18 | - | Aibikita |
| Phenol aimọ | 0.28 | 1.6 | 0.3 |
| DPTTAB | 0.46 | 0.83 | 0.15 |
| Tabi alaimọ | 0.57 | 1.2 | 0.15 |
| Rivastigmine | 1.0 | 1.0 | - |
| Carbamate jẹ alaimọ | 4.1 | 1.3 | 0.15 |
| Eteri aimọ | 6.5 | 1.4 | 0.15 |
| Eyikeyi miiran aimọ | - | 1.0 | 0.1 |
a (S) -3- [1- (Dimethylamino) ethyl] phenol.
b (+) -Di- (p-toluoyl) -d-tartaric acid (apapo ti o ni ibatan rivastigmine).
c (S) -3- [1- (Dimethylamino) ethyl] phenyl dimethylcarbamate (ibarapọ ti o ni ibatan rivastigmine B).
d 3-Nitrofenyl ethyl (methyl) karbamate.
e (S) -N, N-Dimethyl-1-[3- (4-nitrophenoxy) phenyl] etanamine.
• Ilana 2: Enantiomeric Purity
Idaduro: Gbigbe 1.78 g ti dibasic sodium fosifeti dihydrate ati 1.38 g ti monobasic sodium fosifeti sinu ọpọn iwọn didun 1000-mL.Tu sinu ati dilute pẹlu omi si iwọn didun.Ṣatunṣe pẹlu phosphoric acid si pH ti 6.0.
Ipele alagbeka: Gbigbe 20 milimita ti acetonitrile ati 205 µL ti N, N-dimethylotylamine si ọpọn iwọn didun 1000-mL, ati dilute pẹlu Buffer si iwọn didun.
Ojutu boṣewa: 0.1 µg/mL ti USP Rivastigmine Tartrate R-Isomer RS ni ipele Alagbeka
Ojutu ifamọ: 0.05 µg/mL ti USP Rivastigmine Tartrate R-Isomer RS ni apakan Alagbeka, ojutu Standard
Ojutu ibaamu eto: 100 µg/mL ti USP Rivastigmine Tartrate RS ati 0.1 µg/mL ti USP Rivastigmine Tartrate R-Isomer RS ni apakan Alagbeka
Ojutu ayẹwo: 100 µg/mL ti Rivastigmine Tartrate ni alakoso Alagbeka
Eto Chromatographic
(Wo Chromatography <621>, Ibamu Eto.)
Ipo: LC
Oluwari: UV 200 nm
Ọwọn: 4.0-mm × 10-cm;iṣakojọpọ L41
Oṣuwọn sisan: 0.5 milimita / min
Iwọn abẹrẹ: 20µL
Ibamu eto
Awọn ayẹwo: Ojutu boṣewa, Ojutu ifamọ, ati ojutu ibamu eto
Awọn ibeere ibamu
Ipinnu: NLT 0.8 laarin awọn oke enantiomer, ojutu ibamu eto
[Akiyesi-Aṣẹ elution ni R-enantiomer, atẹle nipa oke rivastigmine, eyiti o jẹ S-enantiomer.]
Ipin ifihan agbara-si-ariwo: NLT 10, Ojutu ifamọ
Ojulumo boṣewa iyapa: NMT 10%, Standard ojutu
Onínọmbà
Awọn apẹẹrẹ: Ojutu boṣewa ati ojutu Ayẹwo
Ṣe iṣiro ipin ti R-enantiomer ni apakan Rivastigmine Tartrate ti o mu:
Esi = (rU/rS) × (CS/CU) × 100
rU = idahun ti o ga julọ ti R-enantiomer lati inu ojutu Ayẹwo
rS = idahun ti o ga julọ ti R-enantiomer lati ojutu Standard
CS = ifọkansi ti R-enantiomer ninu ojutu Standard (µg/ml)
CU = ifọkansi ti Rivastigmine Tartrate ninu ojutu Ayẹwo (µg/mL)
Awọn ilana gbigba: NMT 0.3% ti R-enantiomer
Awọn idanwo pataki
• Ipinnu Omi, Ọna Ia <921>: NMT 0.5%
Awọn ibeere afikun
• Iṣakojọpọ ati Ibi ipamọ: Fipamọ sinu awọn apoti wiwu, ati tọju ni iwọn otutu yara.
• Awọn Ilana Itọkasi USP <11>
USP Rivastigmine Tartrate RS
USP Rivastigmine Jẹmọ Agbo A RS
Di-p-toluoyl-d-(+) -tartaric acid monohydrate.
C20H20O9 404.37
USP Rivastigmine Jẹmọ Agbo B RS
N, N-Dimethylcarbamic acid-3-[1- (dimethylamino) ethyl] phenyl ester.
C13H20N2O2 236.32
USP Rivastigmine Tartrate R-Isomer RS
Bawo ni lati Ra?Jọwọ kan siDr. Alvin Huang: sales@ruifuchem.com or alvin@ruifuchem.com
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UN ID UN 2811 6.1 / PGII
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RTECS FA9550000
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Ewu Kilasi 6.1
Iṣakojọpọ Ẹgbẹ III
Rivastigmine Tartrate (CAS: 129101-54-8) jẹ tartrate ti rivastigmine, oogun kan fun itọju arun Alzheimer.Rivastigmine jẹ itọsẹ physostigmine, eyiti o ni idagbasoke ni aṣeyọri fun igba akọkọ nipasẹ Novartis, Switzerland.Orukọ iṣowo naa jẹ exelon, ati pe moleku naa ni eto benzyl carbamate, o jẹ inhibitor cholinesterase ti o yan ọpọlọ-ọpọlọ, eyiti o le ṣe idiwọ acetylcholinesterase ati butyrylcholinesterase ni akoko kanna, ati igbega itọsi aifọkanbalẹ cholinergic nipasẹ idaduro ibajẹ ti acetylcholine ti a tu silẹ nipasẹ cholinergic awọn iṣan.O le mu ailagbara oye ti o ni ilaja nipasẹ cholinergic, nitorinaa imudarasi ipa imọ ti awọn alaisan ti o ni arun Alzheimer.Agbara abuda amuaradagba pilasima ti rivastigmine jẹ alailagbara, rọrun lati kọja nipasẹ idena ọpọlọ-ẹjẹ, ati pe o ni iwọn giga ti yiyan ọpọlọ.Ko le ṣe yiyan nikan ni awọn agbegbe ti o ni ipalara julọ ti kotesi cerebral ati hippocampus, ṣugbọn tun ṣe idiwọ awọn subtypes ti o ga julọ ti AChE ninu ọpọlọ, eyiti o le dinku awọn ipa ẹgbẹ cholinergic agbeegbe lakoko ti o n ṣe awọn ipa arowoto.Igbesi aye idaji ti rivastigmine tartrate ninu ara jẹ kukuru ati akoko iṣe jẹ pipẹ.Ko dabi tacrine, ọja yii ni ipa inhibitory ti o lagbara lori henensiamu G1 ninu hippocampus ati kotesi.O ti wa ni ile-iwosan lati ṣe itọju ailera Alṣheimer kekere tabi iwọntunwọnsi, eyiti a fura si arun Alusaima tabi arun Alṣheimer.
1. Gẹgẹbi oludena acetylcholinesterase, rivastigmine bicartrate le mu ipa ti isinmi ti iṣan succinylcholine dara si.Nitorinaa, o yẹ ki o jẹ akoko ifaramọ ti o yẹ lati da mimu ọja yii duro ṣaaju akuniloorun.Ọja yii yẹ ki o ni idapo pẹlu miiran cholinergic tabi awọn igbaradi anticholinergic, ati pe o yẹ ki o ṣe akiyesi (wo [Ibaraẹnisọrọ Oògùn]).
2. Nitori awọn ipa elegbogi wọn, awọn inhibitors cholinesterase le ni awọn ipa ẹdọfu aifokanbale lori oṣuwọn ọkan.Gẹgẹbi pẹlu awọn oogun cholinergic miiran, iṣọra gbọdọ wa ni adaṣe nigbati o ba fun awọn alaisan ti o ni iṣọn-ẹjẹ ẹṣẹ aiṣan tabi idinamọ ọkan miiran (wo Awọn aati Ibajẹ).
3. Idunnu nafu ara Cholinergic le fa alekun yomijade acid inu.Botilẹjẹpe ko si ẹri ti ibajẹ pataki ti awọn aami aiṣan ti o baamu ni akoko idanwo ile-iwosan, awọn alaisan ti o ni eewu nla ti ọgbẹ inu, gẹgẹbi awọn ti o ni itan-akọọlẹ ti ọgbẹ tabi awọn ti n gba itọju concomitant pẹlu awọn oogun egboogi-iredodo ti kii-sitẹriọdu, yẹ ki o lo pẹlu iṣọra.
4. Gẹgẹbi awọn inhibitors cholinesterase miiran, awọn alaisan ti o ni itan-akọọlẹ ikọ-fèé tabi awọn arun ẹdọforo idena miiran yẹ ki o lo pẹlu iṣọra.
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