Rivastigmine Tartrate CAS 129101-54-8 Assay 98.0~102.0
Shanghai Ruifu Chemical Co., Ltd. ndiyo inotungamira mugadziri weRivastigmine Tartrate (CAS: 129101-54-8) ine mhando yepamusoro.Ruifu Chemical inogona kupa kutumirwa kwepasirese, mutengo wemakwikwi, sevhisi yakanakisa, idiki uye yakawanda huwandu huripo.Tenga Rivastigmine Tartrate,Please contact: alvin@ruifuchem.com
| Chemical Name | Rivastigmine Tartrate |
| Mashoko anoreva zvakafanana | 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 |
| Stock Status | MuStock, Commercial Production |
| Nhamba yeCAS | 129101-54-8 |
| Inoenderana CAS | 123441-03-2 |
| Molecular Formula | C14H22N2O2·C4H6O6 |
| Molecular Weight | 400.43 g/mol |
| Melting Point | 124.0 kusvika 128.0 ℃ |
| Kutenderera kwakananga [a]20/D | +4.0° kusvika +7.0° (C=5, Methanol) |
| Solubility | Soluble muMethanol |
| COA & MSDS | Available |
| Origin | Shanghai, China |
| Brand | Ruifu Chemical |
| Items | Kuongorora Maitiro | Results |
| Chitarisiko | Ichena kusvika kuOff-White Crystalline Powder | Zvinoenderana |
| Assay | 98.0 ~ 102.0% (paiyo Anhydrous Basis) | 99.8% |
| Mvura naKarl Fischer | ≤0.50% | 0.15% |
| Residue paIgnition | ≤0.10% | 0.07% |
| Masimbi anorema (Pb) | ≤20ppm | <10ppm |
| Phenol Kusachena | ≤0.30% | <0.30% |
| DPTTA | ≤0.15% | <0.15% |
| Kana Kusachena | ≤0.15% | <0.15% |
| Carbamate Kusachena | ≤0.15% | <0.15% |
| Ether Kusachena | ≤0.15% | <0.15% |
| Chero Kumwe Kusachena | ≤0.10% | <0.10% |
| Zvose zvisina kuchena | ≤0.50% | <0.50% |
| R-Enantiomer | ≤0.30% | <0.30% |
| Infrared Spectrum | Zvinoenderana NeChimiro | Zvinoenderana |
| 1H NMR Spectrum | Zvinoenderana NeChimiro | Zvinoenderana |
| Mhedziso | Chigadzirwa chakaedzwa uye chinoenderana neUSP35 Standard | |
Package:Fluorinated Bhodhoro, Aluminium foil bag, 25kg/Cardboard Drum, kana zvinoenderana nezvinodiwa nemutengi.
Storage Condition:Chengetedza mudziyo wakavharwa zvakasimba uye chengeta munzvimbo inotonhorera, yakaoma (2~8℃) uye inofefeterwa nemhepo yakanaka kure nezvinhu zvisingaenderane.Dzivirira kubva kuchiedza uye unyoro.
KutumiraKuendesa kupasirese nemhepo, neFedEx / DHL Express.Ipa kutumirwa nekukurumidza uye kwakavimbika.
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].
DEFINITION
Rivastigmine Tartrate ine NLT 98.0% uye NMT 102.0% yehuwandu hwakanyorwa hweC14H22N2O2 · C4H6O6, yakaverengwa pane anhydrous basis.
KUZIVA
• A. Infrared Absorption <197K>
• B. Nguva yekuchengetedza yepamusoro-soro yeSample solution inoenderana neiyo yeSystem suitability solution, sezvakawanikwa muyedzo yeOrganic Impurities, Maitiro 2: Enantiomeric Purity.
ASSAY
• Maitiro
Buffer: 8.6 mg/mL ye monobasic ammonium phosphate.Rongedza neammonia mhinduro kune pH ye7.0.
Nharembozha chikamu: Methanol, acetonitrile, uye Buffer (15:15:70)
Kukodzera kweSystem mhinduro: 0.05 mg/mL imwe neimwe yeUSP Rivastigmine Inoenderana Compound A RS uye USP Rivastigmine Inoenderana Musanganiswa B RS muMobile phase.
Mhinduro yakajairwa: 0.2 mg/mL yeUSP Rivastigmine Tartrate RS muMobile phase
Sample solution: 0.2 mg/mL yeRivastigmine Tartrate muMobile phase
Chromatographic system
(Ona Chromatography <621>, System Suitability.)
Modhi: LC
Detector: UV 215 nm
Column: 4.6-mm × 25-cm;5-µm kurongedza L7
Kuyerera kweyero: 1.2 mL/min
Jekiseni saizi: 20 µL
[Cherechedza-Chiyero chekuyerera chinogona kugadziriswa ku 1.5 mL / min, kana zvichidiwa, kuti uwane yakakurudzirwa kuchengetedza nguva ye rivastigmine inenge 10 min.]
Kukodzera kwehurongwa
Samples: Kukodzera sisitimu mhinduro uye Standard mhinduro
Kukodzera zvinodiwa
Resolution: NLT 1.5 pakati pe rivastigmine inoenderana nekamu A uye rivastigmine ine hukama B, Sistimu yakakodzera mhinduro
Column kunyatsoita: NLT 5000 theoretical plates, Standard solution
Muswe chinhu: NMT 3.0, Standard mhinduro
Relative mwero kutsauka: NMT 2.0%, Standard solution
Analysis
Samples: Yakajairwa mhinduro uye Sample mhinduro
Verenga chikamu cheC14H22N2O2 · C4H6O6 muchikamu cheRivastigmine Tartrate yakatorwa:
Mhedzisiro = (rU/rS) × (CS/CU) × 100
rU = peak mhinduro kubva kuSample solution
rS = mhinduro yepamusoro kubva kune Standard solution
CS = kusangana kweiyo Standard solution (mg/mL)
CU = kusangana kweSample solution (mg/mL)
Maitiro ekugamuchira: 98.0% -102.0% pane anhydrous basis
KUSIRIRA
Inorganic Impurities
• Zvakasara paKubatidza <281>: NMT 0.1%
• Heavy Metals, Method II <231>: NMT 20 ppm
Organic Kusachena
• Maitiro 1
Nharembozha chikamu uye Sisitimu yakakodzera mhinduro: Enderera sekurairwa muAssay.
Yakajairwa mhinduro: 1.0 µg/mL yeUSP Rivastigmine Tartrate RS muchikamu cheMobile
Sample solution: 1.0 mg/mL yeRivastigmine Tartrate muMobile phase
Chromatographic system: Enderera sekurairwa muAssay.
(Ona Chromatography <621>, System Suitability.)
Kukodzera kwehurongwa
Samples: Kukodzera sisitimu mhinduro uye Standard mhinduro
Kukodzera zvinodiwa
Resolution: NLT 1.5 pakati pe rivastigmine inoenderana nekamu A uye rivastigmine ine hukama B, Sistimu yakakodzera mhinduro
Relative mwero kutsauka: NMT 10%, Standard mhinduro
Ongororo [Cherechedza-Nguva yekumhanya ndeye 8 nguva yekuchengeta yerivastigmine peak.]
Samples: Yakajairwa mhinduro uye Sample mhinduro
Verengai muzana yekusachena chero kwemunhu muchikamu cheRivastigmine Tartrate chakatorwa:
Mhedzisiro = (rU/rS) × (CS/CU) × (1/F) × 100
rU = peak mhinduro yekusachena yega yega kubva kuSample solution
rS = mhinduro yepamusoro kubva kune Standard solution
CS = kusungwa kweUSP Rivastigmine Tartrate RS muStandard solution (mg/mL)
CU = kusangana kweRivastigmine Tartrate muSample solution (mg/mL)
F = hama yekupindura chinhu (ona Kusachena Tafura 1)
Maitiro ekugamuchira
Kusachena kwemunhu: Ona Kusachena Tafura 1.
Yese tsvina: NMT 0.5%
Kusachena Tafura 1
| Zita | Relative Retention Time | Relative Response Factor | Maitiro ekugamuchira NMT % |
| Tartrate | 0.18 | - | Kuzvidza |
| Phenol ipuritya | 0.28 | 1.6 | 0.3 |
| DPTTAb | 0.46 | 0.83 | 0.15 |
| Kana kusachena | 0.57 | 1.2 | 0.15 |
| Rivastigmine | 1.0 | 1.0 | - |
| Carbamate isina kuchena | 4.1 | 1.3 | 0.15 |
| Ether kusachena | 6.5 | 1.4 | 0.15 |
| Chero kumwe kusachena | - | 1.0 | 0.1 |
a (S) -3--[1-(Dimethylamino)ethyl]phenol.
b (+)-Di-(p-toluoyl)-d-tartaric acid (rivastigmine inoenderana nekomboni A).
c (S) -3- [1- (Dimethylamino) ethyl] phenyl dimethylcarbamate (rivastigmine ine hukama B).
d 3-Nitrophenyl ethyl(methyl)carbamate.
e (S)-N,N-Dimethyl-1-[3-(4-nitrophenoxy)phenyl]ethanamine.
• Nzira 2: Enantiomeric Purity
Buffer: Kuendesa 1.78 g ye dibasic sodium phosphate dihydrate uye 1.38 g ye monobasic sodium phosphate mu 1000-mL volumetric flask.Dissolve in uye diluted nemvura kusvika kuhuwandu.Gadzirisa nephosphoric acid kusvika pH ye6.0.
Nharembozha nhanho: Kuendesa 20 mL yeacetonitrile uye 205 µL yeN,N-dimethyloctylamine kune 1000-mL volumetric flask, uye dilute neBuffer kusvika kuhuwandu.
Yakajairwa mhinduro: 0.1 µg/mL yeUSP Rivastigmine Tartrate R-Isomer RS muMobile phase
Sensitivity mhinduro: 0.05 µg/mL yeUSP Rivastigmine Tartrate R-Isomer RS muMobile phase, Standard solution
Sistimu yekukodzera mhinduro: 100 µg/mL yeUSP Rivastigmine Tartrate RS uye 0.1 µg/mL yeUSP Rivastigmine Tartrate R-Isomer RS muMobile phase.
Sample solution: 100 µg/mL yeRivastigmine Tartrate muMobile phase
Chromatographic system
(Ona Chromatography <621>, System Suitability.)
Modhi: LC
Detector: UV 200 nm
Column: 4.0-mm × 10-cm;kurongedza L41
Kuyerera kweyero: 0.5 mL/min
Jekiseni saizi: 20 µL
Kukodzera kwehurongwa
Samples: Yakajairwa mhinduro, Sensitivity mhinduro, uye System kukodzera mhinduro
Kukodzera zvinodiwa
Resolution: NLT 0.8 pakati peantiomer peaks, Sistimu yakakodzera mhinduro
[Cherechedza-Iyo elution order iR-enantiomer, inoteverwa nerivastigmine peak, inova S-enantiomer.]
Chiratidzo-ku-ruzha chiyero: NLT 10, Sensitivity mhinduro
Relative mwero kutsauka: NMT 10%, Standard mhinduro
Analysis
Samples: Yakajairwa mhinduro uye Sample mhinduro
Verenga iyo muzana yeR-enantiomer muchikamu cheRivastigmine Tartrate yakatorwa:
Mhedzisiro = (rU/rS) × (CS/CU) × 100
rU = peak mhinduro yeR-enantiomer kubva kuSample solution
rS = mhinduro yepamusoro yeR-enantiomer kubva kuStandard solution
CS = kuunganidzwa kweR-enantiomer muiyo Standard solution (µg/mL)
CU = kusangana kweRivastigmine Tartrate muSample solution (µg/mL)
Maitiro ekugamuchira: NMT 0.3% yeR-enantiomer
ZVIYEDZO ZVAKANAKA
• Kusarudza Mvura, Nzira Ia <921>: NMT 0.5%
ZVIMWE ZVINODIWA
• Kurongedza uye Kuchengeta: Chengetedza mumidziyo yakaoma, uye chengeta patembiricha yepakamuri.
• USP Reference Standards <11>
USP Rivastigmine Tartrate RS
USP Rivastigmine Inoenderana Musanganiswa A RS
Di-p-toluoyl-d-(+)-tartaric acid monohydrate.
C20H20O9 404.37
USP Rivastigmine Inoenderana Musanganiswa 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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Kurongedza Boka III
Rivastigmine Tartrate (CAS: 129101-54-8) ndiyo tartrate ye rivastigmine, mushonga wekurapa chirwere cheAlzheimer.Rivastigmine inotorwa ne physostigmine, iyo yakabudirira kugadzirwa kekutanga neNovartis, Switzerland.Zita rekutengeserana ndiro exelon, uye molecule ine benzyl carbamate structure, inonzi carbamate brain-selective cholinesterase inhibitor, iyo inogona kudzivisa acetylcholinesterase uye butyrylcholinesterase panguva imwe chete, uye inosimudzira cholinergic nerve conduction nekunonoka kuparara kweacetylcholine yakabudiswa necholinergic. neurons.Inogona kuvandudza kusashanda kwekuziva kunopindirana necholinergic, nekudaro ichivandudza cognitive maitiro evarwere vane chirwere cheAlzheimer.Iyo plasma protein inosunga simba re rivastigmine haina simba, iri nyore kupfuura nepakati peropa-brain barriers, uye ine yakanyanya dhigirii yehuropi kusarudza.Iyo haingogone kuita sarudzo munzvimbo dzakanyanya kutambudzika dzecerebral cortex uye hippocampus, asi zvakare inosarudzika inhibisa iyo inotonga subtypes ye AChE muuropi, iyo inogona kuderedza peripheral cholinergic side mhedzisiro ichigadzira kurapa.Iyo hafu yehupenyu ye rivastigmine tartrate mumuviri ipfupi uye nguva yekuita irefu.Kusiyana netacrine, chigadzirwa ichi chine yakasimba inhibitory mhedzisiro paG1 enzyme muhippocampus uye cortex.Inoshandiswa pakurapa kurapa nyoro kusvika pakati nepakati Alzheimer's dementia, iyo inofungidzirwa nezvechirwere cheAlzheimer kana chirwere cheAlzheimer.
1. Se acetylcholinesterase inhibitor, rivastigmine bicartrate inogona kuvandudza mhedzisiro ye succinylcholine tsandanyama inozorodza.Nokudaro, panofanira kuva nenguva yakakodzera yepakati yekurega kutora chigadzirwa ichi pamberi peanesthesia.Ichi chigadzirwa chinofanira kusanganiswa nedzimwe cholinergic kana anticholinergic kugadzirira, uye kuchenjerera kunofanira kutorwa (ona [Drug Interaction]).
2. Pamusana pemigumisiro yavo yemishonga, cholinesterase inhibitors inogona kuva ne vagus nerve tension effects pamwoyo.Sezvimwe nemamwe madhiragi echolinergic, kuchenjerera kunofanira kushandiswa kana kuchipiwa kuvarwere vane chirwere che sinus syndrome kana imwe moyo block (ona Zvakaipa Zvinoita).
3. Cholinergic nerve excitement inogona kukonzera kuwedzera gastric acid secretion.Kunyangwe pasina humbowo hwekuderera kwakakosha kwezviratidzo zvinowirirana zvakawanikwa panguva yekuyedzwa kwekiriniki, varwere vane njodzi yakakura yegastric ulcer, sevaya vane nhoroondo yechirwere cheronda kana avo vanowana kurapwa kwakafanana neasiri-steroidal anti-inflammatory drugs, inofanira kushandiswa nokungwarira.
4. Kufanana nedzimwe cholinesterase inhibitors, varwere vane nhoroondo yeasthma kana zvimwe zvirwere zvinodzivirira zvemapapu zvinofanira kushandiswa nekuchenjerera.
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