Rivastigmine Tartrate CAS 129101-54-8 Assay 98.0 ~ 102.0
Shanghai Ruifu Chemical Co., Ltd. ndi omwe amapanga Rivastigmine Tartrate (CAS: 129101-54-8) yokhala ndi mawonekedwe apamwamba.Ruifu Chemical imatha kubweretsa padziko lonse lapansi, mtengo wampikisano, ntchito zabwino kwambiri, zochepa komanso zochulukirapo zomwe zilipo.Gulani Rivastigmine Tartrate,Please contact: alvin@ruifuchem.com
| Dzina la Chemical | Rivastigmine Tartrate |
| Mawu ofanana ndi mawu | Exellon;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 |
| Stock Status | Mu Stock, Commercial Production |
| Nambala ya CAS | 129101-54-8 |
| Zogwirizana ndi CAS | 123441-03-2 |
| Molecular Formula | C14H22N2O2·C4H6O6 |
| Kulemera kwa Maselo | 400.43 g / mol |
| Melting Point | 124.0 mpaka 128.0 ℃ |
| Kusinthasintha Kwachindunji [a]20/D | +4.0° mpaka +7.0° (C=5, Methanol) |
| Kusungunuka | Zosungunuka mu Methanol |
| COA & MSDS | Likupezeka |
| Chiyambi | Shanghai, China |
| Mtundu | Ruifu Chemical |
| Zinthu | Miyezo Yoyendera | Zotsatira |
| Maonekedwe | Ufa Wa Crystalline Woyera mpaka Woyera | Zimagwirizana |
| Kuyesa | 98.0 ~ 102.0% (pa Anhydrous Basis) | 99.8% |
| Madzi ndi Karl Fischer | ≤0.50% | 0.15% |
| Zotsalira pa Ignition | ≤0.10% | 0.07% |
| Zitsulo Zolemera (Pb) | ≤20ppm | <10ppm |
| Phenol Impurity | ≤0.30% | <0.30% |
| Chithunzi cha DPTTA | ≤0.15% | <0.15% |
| Kapena Chidetso | ≤0.15% | <0.15% |
| Kusayera kwa Carbamate | ≤0.15% | <0.15% |
| Chidetso cha Ether | ≤0.15% | <0.15% |
| Chidetso China Chilichonse | ≤0.10% | <0.10% |
| Zonyansa zonse | ≤0.50% | <0.50% |
| R-Enantiomer | ≤0.30% | <0.30% |
| Infrared Spectrum | Zogwirizana ndi Kapangidwe | Zimagwirizana |
| 1H NMR Spectrum | Zogwirizana ndi Kapangidwe | Zimagwirizana |
| Mapeto | Chogulitsacho chayesedwa ndipo chikugwirizana ndi USP35 Standard | |
Phukusi:Botolo la Fluorinated, thumba la Aluminiyamu zojambulazo, 25kg / Cardboard Drum, kapena malinga ndi zomwe kasitomala amafuna.
Mkhalidwe Wosungira:Sungani chidebecho chotsekedwa mwamphamvu ndikusunga pamalo ozizira, owuma (2~8 ℃) komanso molowera mpweya wabwino kutali ndi zinthu zomwe sizingagwirizane.Tetezani ku kuwala ndi chinyezi.
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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].
TANTHAUZO
Rivastigmine Tartrate ili ndi NLT 98.0% ndi NMT 102.0% ya ndalama zolembedwa za C14H22N2O2·C4H6O6, zowerengedwa pa maziko a anhydrous.
CHIZINDIKIRO
• A. Infrared Absorption <197K>
• B. Nthawi yosungirako pachimake chachikulu cha Sample solution ikufanana ndi ya System suitability solution, monga momwe tapezekera pakuyesa kwa Organic Impurities, Ndondomeko 2: Enantiomeric Purity.
ZOYESA
• Ndondomeko
Chosungira: 8.6 mg/mL wa monobasic ammonium phosphate.Sinthani ndi yankho la ammonia kukhala pH ya 7.0.
Gawo lam'manja: Methanol, acetonitrile, ndi Buffer (15:15:70)
Njira yothetsera kuyenerera kwadongosolo: 0.05 mg/mL iliyonse ya USP Rivastigmine Yogwirizana Compound A RS ndi USP Rivastigmine Yogwirizana Compound B RS mu gawo la Mobile
Yankho lokhazikika: 0.2 mg/mL ya USP Rivastigmine Tartrate RS mu gawo la Mobile
Yankho lachitsanzo: 0.2 mg / mL ya Rivastigmine Tartrate mu gawo la Mobile
Chromatographic system
(Onani Chromatography <621>, Kukwanira Kwadongosolo.)
Njira: LC
Chowunikira: UV 215 nm
Mzere: 4.6-mm × 25-cm;5-µm kunyamula L7
Kuthamanga: 1.2 mL / min
Kukula kwa jekeseni: 20µL
[Zindikirani-Kuthamanga kwa magazi kungasinthidwe kukhala 1.5 mL / min, ngati kuli kofunikira, kuti mukwaniritse nthawi yosungirako ya rivastigmine pafupifupi 10 min.]
Kuyenerera kwadongosolo
Zitsanzo: Njira yothetsera kuyenerera kwadongosolo ndi njira yokhazikika
Zofunikira zoyenera
Kusamvana: NLT 1.5 pakati pa rivastigmine yokhudzana ndi chigawo A ndi rivastigmine yogwirizana ndi B, Njira yothetsera vuto
Kuchita bwino kwa mzati: NLT 5000 theoretical plates, Standard solution
Chinthu chokhazikika: NMT 3.0, njira yokhazikika
Kupatuka kofananira: NMT 2.0%, njira yokhazikika
Kusanthula
Zitsanzo: Yankho lokhazikika ndi yankho lachitsanzo
Werengani kuchuluka kwa C14H22N2O2·C4H6O6 mu gawo la Rivastigmine Tartrate yotengedwa:
Zotsatira = (rU/rS) × (CS/CU) × 100
rU = kuyankha kwapamwamba kuchokera ku Sample solution
rS = kuyankha kwakukulu kuchokera ku Standard solution
CS = kuchuluka kwa njira yokhazikika (mg/mL)
CU = ndende ya Sample solution (mg/mL)
Njira zolandirira: 98.0% -102.0% pamaziko a anhydrous
ZOCHITSA
Zowonongeka Zachilengedwe
• Zotsalira pakuyatsa <281>: NMT 0.1%
• Zitsulo Zolemera, Njira II <231>: NMT 20 ppm
Zowonongeka Zachilengedwe
• Ndondomeko 1
Mobile phase and System suitability solution: Pitirizani monga mwauzira mu Assay.
Yankho lokhazikika: 1.0 µg/mL ya USP Rivastigmine Tartrate RS mu gawo la Mobile
Yankho lachitsanzo: 1.0 mg / mL ya Rivastigmine Tartrate mu gawo la Mobile
Chromatographic system: Pitirizani monga momwe mukuyendera mu Assay.
(Onani Chromatography <621>, Kukwanira Kwadongosolo.)
Kuyenerera kwadongosolo
Zitsanzo: Njira yothetsera kuyenerera kwadongosolo ndi njira yokhazikika
Zofunikira zoyenera
Kusamvana: NLT 1.5 pakati pa rivastigmine yokhudzana ndi chigawo A ndi rivastigmine yogwirizana ndi B, Njira yothetsera vuto
Kupatuka kofananira: NMT 10%, njira yokhazikika
Kusanthula [Zindikirani-Nthawi yothamanga ndi nthawi 8 kuposa nthawi yosungira pachimake cha rivastigmine.]
Zitsanzo: Yankho lokhazikika ndi yankho lachitsanzo
Werengani kuchuluka kwa zodetsa zilizonse zomwe zatengedwa mu Rivastigmine Tartrate:
Zotsatira = (rU/rS) × (CS/CU) × (1/F) × 100
rU = kuyankha pachimake pachidetso chilichonse kuchokera ku Sample solution
rS = kuyankha kwakukulu kuchokera ku Standard solution
CS = kuchuluka kwa USP Rivastigmine Tartrate RS mu Standard solution (mg/mL)
CU = kuchuluka kwa Rivastigmine Tartrate mu Sample solution (mg/mL)
F = chinthu choyankhirako (onani Table 1)
Zovomerezeka zovomerezeka
Zodetsedwa zapayekha: Onani Table 1.
Zonyansa zonse: NMT 0.5%
Table 1
| Dzina | Nthawi Yachibale Yosunga | Chibale Mayankho Factor | Zoyenera Kulandila NMT % |
| Tartrate | 0.18 | - | Kunyalanyaza |
| Phenol impuritya | 0.28 | 1.6 | 0.3 |
| Chithunzi cha DPTTAb | 0.46 | 0.83 | 0.15 |
| Kapena chidetso | 0.57 | 1.2 | 0.15 |
| Rivastigmine | 1.0 | 1.0 | - |
| Carbamate wodetsedwa | 4.1 | 1.3 | 0.15 |
| Etha wosayera | 6.5 | 1.4 | 0.15 |
| Chidetso china chirichonse | - | 1.0 | 0.1 |
a (S) -3--[1-(Dimethylamino)ethyl]phenol.
b (+)-Di-(p-toluoyl)-d-tartaric acid (rivastigmine yokhudzana ndi mankhwala A).
c (S) -3- [1- (Dimethylamino) ethyl] phenyl dimethylcarbamate (rivastigmine yokhudzana ndi gulu B).
d 3-Nitrophenyl ethyl(methyl)carbamate.
e (S)-N,N-Dimethyl-1-[3-(4-nitrophenoxy)phenyl]ethanamine.
• Ndondomeko 2: Enantiomeric Purity
Chosungira: Chotsani 1.78 g ya dibasic sodium phosphate dihydrate ndi 1.38 g ya monobasic sodium phosphate mu botolo la volumetric 1000-mL.Sungunulani ndi kuchepetsa ndi madzi kuti voliyumu.Sinthani ndi phosphoric acid kukhala pH ya 6.0.
Gawo la m'manja: Chotsani 20 mL ya acetonitrile ndi 205 µL ya N,N-dimethyloctylamine ku botolo la voliyumu ya 1000-mL, ndi kusungunula ndi Buffer ku voliyumu.
Yankho lokhazikika: 0.1 µg/mL ya USP Rivastigmine Tartrate R-Isomer RS mu gawo la Mobile
Yankho lokhudzika: 0.05 µg/mL ya USP Rivastigmine Tartrate R-Isomer RS mu gawo la Mobile, yankho lokhazikika
Njira yothetsera kuyenerera kwadongosolo: 100 µg/mL ya USP Rivastigmine Tartrate RS ndi 0.1 µg/mL ya USP Rivastigmine Tartrate R-Isomer RS mu gawo la Mobile
Yankho lachitsanzo: 100 µg/mL ya Rivastigmine Tartrate mu gawo la Mobile
Chromatographic system
(Onani Chromatography <621>, Kukwanira Kwadongosolo.)
Njira: LC
Chowunikira: UV 200 nm
Mzere: 4.0-mm × 10-cm;kunyamula L41
Kuthamanga: 0.5 mL / min
Kukula kwa jekeseni: 20µL
Kuyenerera kwadongosolo
Zitsanzo: Yankho lokhazikika, Yankho la Sensitivity, ndi njira yoyenerera System
Zofunikira zoyenera
Kusamvana: NLT 0.8 pakati pa nsonga za enantiomer, Njira yothetsera kuyenerera
[Zindikirani-Lamulo la elution ndi R-enantiomer, yotsatiridwa ndi rivastigmine nsonga, yomwe ndi S-enantiomer.]
Chiŵerengero cha Signal-to-Noise: NLT 10, Sensitivity solution
Kupatuka kofananira: NMT 10%, njira yokhazikika
Kusanthula
Zitsanzo: Yankho lokhazikika ndi yankho lachitsanzo
Kuwerengera kuchuluka kwa R-enantiomer mu gawo la Rivastigmine Tartrate yotengedwa:
Zotsatira = (rU/rS) × (CS/CU) × 100
rU = kuyankha kwakukulu kwa R-enantiomer kuchokera ku Sample solution
rS = kuyankha kwapamwamba kwa R-enantiomer kuchokera ku Standard solution
CS = kuchuluka kwa R-enantiomer mu Standard solution (µg/mL)
CU = kuchuluka kwa Rivastigmine Tartrate mu Sample solution (µg/mL)
Njira zolandirira: NMT 0.3% ya R-enantiomer
MAYESO AKE
• Kutsimikiza kwa Madzi, Njira Ia <921>: NMT 0.5%
ZOWONJEZERA ZOFUNIKA
• Kupaka ndi Kusunga: Isungireni m’zotengera zothina, ndipo sungani pamalo otentha.
• USP Reference Standards <11>
USP Rivastigmine Tartrate RS
USP Rivastigmine Related Compound A RS
Di-p-toluoyl-d-(+)-tartaric asidi monohydrate.
C20H20O9 404.37
USP Rivastigmine Yogwirizana Compound B RS
N,N-Dimethylcarbamic acid-3--[1-(dimethylamino)ethyl]phenyl ester.
Chithunzi cha C13H20N2O2 236.32
USP Rivastigmine Tartrate R-Isomer RS
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Rivastigmine Tartrate (CAS: 129101-54-8) ndi tartrate ya rivastigmine, mankhwala ochizira matenda a Alzheimer's.Rivastigmine ndi physostigmine yochokera, yomwe idapangidwa bwino kwa nthawi yoyamba ndi Novartis, Switzerland.Dzina la malonda ndi exelon, ndipo molekyu ili ndi benzyl carbamate dongosolo, ndi carbamate brain-selective cholinesterase inhibitor, yomwe ingalepheretse acetylcholinesterase ndi butyrylcholinesterase panthawi imodzimodziyo, ndikulimbikitsanso mitsempha ya cholinergic mwa kuchepetsa kuwonongeka kwa acetylcholine yotulutsidwa ndi cholinergic. ma neurons.Itha kusintha kusokonezeka kwachidziwitso komwe kumayendetsedwa ndi cholinergic, potero kumathandizira kuzindikira kwa odwala omwe ali ndi matenda a Alzheimer's.Mapuloteni a plasma omwe amamanga mphamvu ya rivastigmine ndi ofooka, osavuta kudutsa chotchinga chamagazi-muubongo, ndipo amakhala ndi mwayi wosankha ubongo.Sizingatheke kusankha madera omwe ali pachiwopsezo cha cerebral cortex ndi hippocampus, komanso kuletsa mwapadera magulu ang'onoang'ono a AChE muubongo, omwe amatha kuchepetsa zotumphukira za cholinergic pomwe akupanga zochiritsa.Theka la moyo wa rivastigmine tartrate m'thupi ndi lalifupi ndipo nthawi yochitapo kanthu ndi yaitali.Mosiyana ndi tacrine, mankhwalawa ali ndi mphamvu yoletsa kwambiri G1 enzyme mu hippocampus ndi cortex.Amagwiritsidwa ntchito pochiza matenda a dementia pang'ono mpaka pang'ono, omwe akuganiziridwa kuti ndi matenda a Alzheimer's kapena Alzheimer's.
1. Monga acetylcholinesterase inhibitor, rivastigmine bicartrate ikhoza kusintha zotsatira za succinylcholine minofu yopumula.Choncho, payenera kukhala nthawi yoyenera yapakatikati kuti musiye kumwa mankhwalawa musanayambe opaleshoni.Izi ziyenera kuphatikizidwa ndi mankhwala ena a cholinergic kapena anticholinergic, ndipo kusamala kuyenera kutengedwa (onani [Kuyanjana kwa Mankhwala]).
2. Chifukwa cha zotsatira za pharmacological, cholinesterase inhibitors akhoza kukhala ndi vuto la mitsempha ya vagus pa kugunda kwa mtima.Mofanana ndi mankhwala ena a cholinergic, kusamala kuyenera kuperekedwa kwa odwala omwe ali ndi matenda a sinus kapena matenda ena amtima (onani Zowonongeka Zoyipa).
3. Cholinergic mitsempha chisangalalo chingayambitse kuchuluka kwa asidi m'mimba.Ngakhale kuti palibe umboni wosonyeza kuwonongeka kwakukulu kwa zizindikiro zofanana zomwe zinapezeka panthawi ya mayesero a zachipatala, odwala omwe ali ndi chiopsezo chachikulu chokhala ndi zilonda zam'mimba, monga omwe ali ndi mbiri ya matenda a zilonda zam'mimba kapena omwe akulandira chithandizo chofanana ndi mankhwala osagwiritsa ntchito steroidal anti-inflammatory, ziyenera kugwiritsidwa ntchito mosamala.
4. Mofanana ndi zoletsa zina za cholinesterase, odwala omwe ali ndi mbiri ya mphumu kapena matenda ena a m'mapapo ayenera kugwiritsidwa ntchito mosamala.
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