Rivastigmine Tartrate CAS 129101-54-8 Su'ega 98.0~102.0
Shanghai Ruifu Chemical Co., Ltd. o le taʻutaʻua taʻutaʻua o Rivastigmine Tartrate (CAS: 129101-54-8) faʻatasi ai ma tulaga maualuga.Ruifu Chemical e mafai ona tuʻuina atu i le lalolagi atoa, tau faʻatauvaʻa, auaunaga sili ona lelei, laʻititi ma tele tele o loʻo avanoa.Fa'atau Rivastigmine Tartrate,Please contact: alvin@ruifuchem.com
| Igoa Vailaau | Rivastigmine Tartrate |
| Synonyms | Eselon;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 |
| Tulaga Fa'asoa | I Fa'atauga, Gaosiga Fa'apisinisi |
| Numera CAS | 129101-54-8 |
| Fa'atatau CAS | 123441-03-2 |
| Fuafua mole | C14H22N2O2·C4H6O6 |
| Molecular Weight | 400.43 g/mol |
| Lisi Lisi | 124.0 i le 128.0 ℃ |
| Ta'amilosaga Fa'apitoa [a]20/D | +4.0° i le +7.0° (C=5, Methanol) |
| Solubility | Solu i le Methanol |
| COA & MSDS | Avanoa |
| Amataga | Shanghai, Saina |
| Fa'ailoga | Ruifu Chemical |
| Aitema | Tulaga Fa'atonu | I'uga |
| Fa'aaliga | Pa'epa'e i le Pa'u Pa'epa'e Pa'epa'e | E usitaia |
| Su'ega | 98.0~102.0% (i luga o le Anhydrous Basis) | 99.8% |
| Vai saunia e Karl Fischer | ≤0.50% | 0.15% |
| Toega i luga o le mumu | ≤0.10% | 0.07% |
| Metala mamafa (Pb) | ≤20ppm | <10ppm |
| Phenol Le mama | ≤0.30% | <0.30% |
| DPTTA | ≤0.15% | <0.15% |
| Po o le le mama | ≤0.15% | <0.15% |
| Carbamate Le mama | ≤0.15% | <0.15% |
| Eteru Le mama | ≤0.15% | <0.15% |
| So'o se isi mea le mama | ≤0.10% | <0.10% |
| Aofa'i le mama | ≤0.50% | <0.50% |
| R-Enantiomer | ≤0.30% | <0.30% |
| Alaleo Infrared | Ia ogatasi ma le Fauga | E usitaia |
| 1H NMR Alaleo | Ia ogatasi ma le Fauga | E usitaia |
| Fa'ai'uga | Ua uma ona fa'ata'ita'iina le oloa ma fa'amalieina le USP35 Standard | |
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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].
FAAMATALAGA
Rivastigmine Tartrate o loʻo i ai le NLT 98.0% ma le NMT 102.0% o le aofaʻi o le igoa o le C14H22N2O2 · C4H6O6, faʻatatau i luga o le faʻavae anhydrous.
FAATINOGA
• A. Infrared absorption <197K>
• B. O le taimi fa'atumauina o le tumutumu tele o le fa'ata'ita'iga fofo e fetaui ma le fa'aogaina o le fa'aoga talafeagai, e pei ona maua i le su'ega mo Organic Impurities, Fa'asologa 2: Enantiomeric Purity.
SU'ESU'EGA
• Taualumaga
Pa'u: 8.6 mg/mL ole monobasic ammonium phosphate.Fetuuna'i ile vaifofo ammonia ile pH ole 7.0.
Vaega feavea'i: Methanol, acetonitrile, ma le Pa'u (15:15:70)
Fofo talafeagai o faiga: 0.05 mg/mL ta'itasi USP Rivastigmine Fa'atatau Fa'atasi A RS ma USP Rivastigmine Fa'atatau B RS ile vaega feavea'i.
Fofo masani: 0.2 mg/mL o le USP Rivastigmine Tartrate RS i le vaega Mobile
Fa'ata'ita'iga fofo: 0.2 mg/mL o Rivastigmine Tartrate i le vaega feavea'i
Faiga fa'akomepiuta
(Va'ai Chromatography <621>, Faiga Fa'atonu.)
Auala: LC
Su'esu'e: UV 215 nm
Koluma: 4.6-mm × 25-cm;5-µm fa'apipi'i L7
Fuafuaga tafe: 1.2 mL/min
Tele tui: 20 µL
[Manatua-E mafai ona fetuuna'i le fua faatatau o le tafe i le 1.5 mL/min, pe a mana'omia, ina ia ausia se taimi fa'atumauina o le rivastigmine pe a ma le 10 min.]
Faiga talafeagai
Fa'ata'ita'iga: Fa'atonuga fa'aoga vaifofo ma fofo Fa'atonu
Mana'oga talafeagai
I'uga: NLT 1.5 i le va o le rivastigmine feso'ota'i fa'atasi A ma le rivastigmine fa'afeso'ota'i fa'atasi B, Fa'atonu fa'aoga fofo
Fa'atonuga o le koluma: NLT 5000 papatusi fa'apitoa, Fofo masani
Fa'ailoga fa'ailoga: NMT 3.0, Fofo masani
Feso'ota'iga va'aiga: NMT 2.0%, Fofo masani
Iloiloga
Faʻataʻitaʻiga: Fofo masani ma Faʻataʻitaʻiga fofo
Fa'atatau le pasene ole C14H22N2O2·C4H6O6 ile vaega ole Rivastigmine Tartrate na ave:
I'uga = (rU/rS) × (CS/CU) × 100
rU = tali maualuga mai le faʻataʻitaʻiga fofo
rS = tali pito i luga mai le fofo masani
CS = fa'atonuga ole vaifofo masani (mg/mL)
CU = fa'atonuga o le fa'ata'ita'iga fofo (mg/mL)
Tulaga taliaina: 98.0% -102.0% i luga o le fa'avae anhydrous
LELEI
Fa'aleaga Fa'aletino
• Toega ile mumu <281>: NMT 0.1%
• Metala mamafa, Metotia II <231>: NMT 20 ppm
Oona Fa'aleaga
• Faiga 1
Vaega feavea'i ma Fofo talafeagai Faiga: Fa'agasolo e pei ona fa'atonuina ile Su'ega.
Fofo masani: 1.0 µg/mL o le USP Rivastigmine Tartrate RS ile vaega feavea'i
Fa'ata'ita'iga fofo: 1.0 mg/mL o Rivastigmine Tartrate i le vaega feavea'i
Chromatographic system: Faʻaauau e pei ona faʻatonuina i le Suʻega.
(Va'ai Chromatography <621>, Faiga Fa'atonu.)
Faiga talafeagai
Fa'ata'ita'iga: Fa'atonuga fa'aoga vaifofo ma fofo Fa'atonu
Mana'oga talafeagai
I'uga: NLT 1.5 i le va o le rivastigmine feso'ota'i fa'atasi A ma le rivastigmine fa'afeso'ota'i fa'atasi B, Fa'atonu fa'aoga fofo
Feso'ota'iga tulaga masani: NMT 10%, Fofo masani
Su'esu'ega [Fa'aaliga-O le taimi tamo'e e 8 taimi ole taimi fa'atumauina o le tumutumu rivastigmine.]
Faʻataʻitaʻiga: Fofo masani ma Faʻataʻitaʻiga fofo
Fa'atusatusa le pasene o so'o se tagata le mama i le vaega o le Rivastigmine Tartrate na ave:
I'uga = (rU/rS) × (CS/CU) × (1/F) × 100
rU = tali maualuga mo le mama taʻitasi mai le faʻataʻitaʻiga fofo
rS = tali pito i luga mai le fofo masani
CS = fa'atonuga o le USP Rivastigmine Tartrate RS i le vaifofo masani (mg/mL)
CU = fa'atonuga o le Rivastigmine Tartrate i le fa'ata'ita'iga fofo (mg/mL)
F = fa'atatau tali tali (silasila i le Fuafuaga Le mama 1)
Tulaga taliaina
Fa'aleaga tagata ta'ito'atasi: Va'ai Fuafuaga Le mama 1.
Aofa'iga o mea leaga: NMT 0.5%
Fa'aleaga Laulau 1
| Igoa | Taimi Fa'amaufa'atasiga | Fa'atatau Tali | Ta'iala Talia NMT % |
| Tartrate | 0.18 | — | Le amanaia |
| Phenol le mama | 0.28 | 1.6 | 0.3 |
| DPTTAb | 0.46 | 0.83 | 0.15 |
| Po o le le mamac | 0.57 | 1.2 | 0.15 |
| Rivastigmine | 1.0 | 1.0 | — |
| Carbamate leaga | 4.1 | 1.3 | 0.15 |
| Eteru le mama | 6.5 | 1.4 | 0.15 |
| So'o se isi mea leaga | — | 1.0 | 0.1 |
a (S)-3-[1-(Dimethylamino)ethyl]phenol.
b (+)-Di-(p-toluoyl)-d-tartaric acid (rivastigmine related compound A).
c (S)-3-[1-(Dimethylamino)ethyl]phenyl dimethylcarbamate (rivastigmine feso'ota'i fa'atasi B).
d 3-Nitrophenyl ethyl(methyl)carbamate.
e (S)-N,N-Dimethyl-1-[3-(4-nitrophenoxy)phenyl]ethanamine.
• Faiga 2: Enantiomeric Purity
Pa'u: Fa'aliliu le 1.78 g o le dibasic sodium phosphate dihydrate ma le 1.38 g o le sodium phosphate monobasic i totonu o se fagu volumetric 1000-mL.Fa'amuta i totonu ma fa'afefe i le vai i le voluma.Fetuuna'i ile phosphoric acid ile pH ole 6.0.
Vaega fe'avea'i: Fa'aliliu le 20 mL o le acetonitrile ma le 205 µL o le N,N-dimethyloctylamine i se fagu volumetric 1000-mL, ma fa'afefe i le Pa'u i le voluma.
Fofo masani: 0.1 µg/mL o le USP Rivastigmine Tartrate R-Isomer RS ile vaega feavea'i
Fofo ma'ale'ale: 0.05 µg/mL ole USP Rivastigmine Tartrate R-Isomer RS ile vaega feavea'i, Fofo masani.
Fofo talafeagai o le faiga: 100 µg/mL o le USP Rivastigmine Tartrate RS ma le 0.1 µg/mL o le USP Rivastigmine Tartrate R-Isomer RS ile vaega feavea'i.
Fa'ata'ita'iga fofo: 100 µg/mL o Rivastigmine Tartrate ile vaega feavea'i
Faiga fa'akomepiuta
(Va'ai Chromatography <621>, Faiga Fa'atonu.)
Auala: LC
Su'esu'e: UV 200 nm
Koluma: 4.0-mm × 10-cm;afifiina L41
Fuafuaga tafe: 0.5 mL/min
Tele tui: 20 µL
Faiga talafeagai
Faʻataʻitaʻiga: Fofo masani, Fofo maʻaleʻale, ma le faʻaogaina o le System solution
Mana'oga talafeagai
I'uga: NLT 0.8 i le va o tumutumu o le enantiomer, Faiga talafeagai fofo
[Manatua-O le faʻatonuga o le elution o le R-enantiomer, sosoo ai ma le rivastigmine peak, o le S-enantiomer.]
Fa'ailo-i-leo pisapisao: NLT 10, Fofo maaleale
Feso'ota'iga tulaga masani: NMT 10%, Fofo masani
Iloiloga
Faʻataʻitaʻiga: Fofo masani ma Faʻataʻitaʻiga fofo
Fa'atatau le pasene o le R-enantiomer ile vaega ole Rivastigmine Tartrate na ave:
I'uga = (rU/rS) × (CS/CU) × 100
rU = tali pito i luga ole R-enantiomer mai le fofo Faʻataʻitaʻiga
rS = tali maualuga o le R-enantiomer mai le vaifofo masani
CS = fa'asalaina o le R-enantiomer i le vaifofo masani (µg/mL)
CU = fa'atonuga o le Rivastigmine Tartrate i le fa'ata'ita'iga fofo (µg/mL)
Tulaga talia: NMT 0.3% o le R-enantiomer
SU'E FA'AMANATU
• Fuafuaga Suavai, Metotia Ia <921>: NMT 0.5%
FAAOPOOPOGA
• Fa'apipi'i ma Teuina: Fa'asaoina i totonu o atigipusa fufusi, ma teu i le potu vevela.
• USP Reference Standards <11>
USP Rivastigmine Tartrate RS
USP Rivastigmine Related Compound A RS
Di-p-toluoyl-d-(+)-tartaric acid monohydrate.
C20H20O9 404.37
USP Rivastigmine Related Compound B RS
N,N-Dimethylcarbamic acid-3-[1-(dimethylamino)ethyl]phenyl ester.
C13H20N2O2 236.32
USP Rivastigmine Tartrate R-Isomer RS
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UN ID UN 2811 6.1 / PGII
WGK Siamani 3
RTECS FA9550000
HS Code 29242990
Vasega o Tulaga Lamatia 6.1
Vaega fa'aputu III
Rivastigmine Tartrate (CAS: 129101-54-8) o le tartrate o le rivastigmine, o se vailaʻau mo togafitiga o le faʻamaʻi o le Alzheimer.Rivastigmine o se physostigmine derivative, lea na faʻaleleia lelei mo le taimi muamua e Novartis, Suiselani.O le igoa tau fefaʻatauaʻiga o le exelon, ma o le mole o loʻo i ai se fausaga benzyl carbamate, o le carbamate faiʻai-filifili cholinesterase inhibitor, lea e mafai ona taofia acetylcholinesterase ma butyrylcholinesterase i le taimi lava e tasi, ma faʻaleleia le faʻaogaina o neura cholinergic e ala i le faʻatuai o le faʻaleagaina o le acetylcholine faʻamalolo e le cholinergic. neu.E mafai ona faʻaleleia le faʻafitauli o le mafaufau e ala i le cholinergic, ma faʻaleleia atili ai le mafaufau o tagata mamaʻi e maua i le faʻamaʻi o le Alzheimer.O le malosi o le fusifusia o le rivastigmine i le plasma e vaivai, e faigofie ona pasia le pa puipui o le toto-faiʻai, ma e maualuga le maualuga o le filifili faiʻai.E le gata e mafai ona galue i luga o vaega sili ona vaivai o le cerebral cortex ma le hippocampus, ae faʻapitoa foʻi ona faʻalavelaveina subtypes iloga o le AChE i totonu o le faiʻai, lea e mafai ona faʻaitiitia ai aʻafiaga o le cholinergic peripheral aʻo faia aʻafiaga faʻamalolo.O le afa-ola o le rivastigmine tartrate i totonu o le tino e puupuu ma o le taimi o gaioiga e umi.E le pei o le tacrine, o lenei oloa e sili atu le malosi o le faʻaogaina o le G1 enzyme i le hippocampus ma le cortex.O lo'o fa'aaogaina fa'afoma'i e togafitia ai le tu'inanau o le Alzheimer, lea e masalomia o le fa'ama'i o le Alzheimer po'o le fa'ama'i o le Alzheimer.
1. I le avea ai o se inhibitor acetylcholinesterase, rivastigmine bicartrate e mafai ona faʻaleleia le aʻafiaga o le succinylcholine muscle relaxant.O le mea lea, e tatau ona i ai se taimi fa'aletonu talafeagai e taofi ai le tagofia o lenei oloa a'o le'i fa'ama'i fa'ama'i.O lenei oloa e tatau ona tuʻufaʻatasia ma isi vailaʻau cholinergic poʻo anticholinergic, ma e tatau ona faʻaeteete (silasila i le [Vaʻau Fesoʻotaʻiga]).
2. Ona o latou aafiaga fa'afoma'i, cholinesterase inhibitors e mafai ona i ai a'afiaga o le neura vagus i luga o le fatu.E pei o isi vailaʻau cholinergic, e tatau ona faʻaalia le faʻaeteete pe a tuʻuina atu i tagata mamaʻi e maua i le maʻi sinus maʻi poʻo isi poloka fatu (silasila i Faʻafitauli Faʻaleagaina).
3. O le fiafia o le neura cholinergic e mafai ona fa'atupuina ai le fa'atupuina o le ga'o ga'o.E ui lava e leai se faʻamaoniga o le faʻaleagaina tele o faʻamaoniga tutusa na maua i le vaitaimi o suʻesuʻega falemaʻi, o tagata mamaʻi e maualuga le lamatiaga o le maʻi o le gastric, e pei oi latou o loʻo i ai se talaʻaga o faʻamaʻi maʻi poʻo i latou o loʻo mauaina togafitiga faʻatasi ma vailaʻau faʻamaʻi e le o ni steroidal, e tatau ona fa'aogaina ma le fa'aeteete.
4. E pei o isi inhibitors cholinesterase, e tatau ona faʻaogaina ma le faʻaeteete tagata mamaʻi o loʻo i ai se talaʻaga o le sela poʻo isi faʻamaʻi pipisi.
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