Tom ntej: Rivastigmine Tartrate CAS 129101-54-8 Assay 98.0 ~ 102.0
Shanghai Ruifu Chemical Co., Ltd. yog cov chaw tsim khoom ntawm Rivastigmine Tartrate (CAS: 129101-54-8) nrog cov khoom zoo.Ruifu Chemical tuaj yeem muab kev xa khoom thoob ntiaj teb, tus nqi sib tw, kev pabcuam zoo heev, me me thiab ntau ntau muaj.Yuav Rivastigmine Tartrate,Please contact: alvin@ruifuchem.com
| Tshuaj npe | Rivastigmine Tartrate |
| Synonyms | 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 |
| Tshuag xwm txheej | Hauv Tshuag, Kev Lag Luam Ntau Lawm |
| CAS Nr | 129101-54-8 |
| Related CAS | 123441-03-2 |
| Molecular Formula | C14H22N2O2 · C4H6O6 |
| Molecular Luj | 400.43 g / mol |
| Melting Point | 124.0 txog 128.0 ℃ |
| Kev sib hloov tshwj xeeb [a]20/D | +4.0 ° txog +7.0 ° C = 5, Methanol |
| Solubility | Soluble hauv Methanol |
| COA & MSDS | Muaj |
| Keeb kwm | Shanghai, Suav |
| Hom | Ruifu Tshuaj |
| Cov khoom | Kev soj ntsuam Standards | Cov txiaj ntsig |
| Qhov tshwm sim | Dawb rau Off-White Crystalline Hmoov | Ua raws |
| Assay | 98.0 ~ 102.0% (raws li Anhydrous Basis) | 99.8% |
| Dej los ntawm Karl Fischer | ≤0.50% | 0.15% |
| Residue ntawm Ignition | ≤0.10% | 0.07% |
| Heavy Metals (Pb) | ≤ 20ppm | <10ppm |
| Phenol impurity | ≤ 0.30% | <0.30% |
| DPTTA | ≤ 0.15% | <0.15% |
| Tsis yog impurity | ≤ 0.15% | <0.15% |
| Carbamate impurity | ≤ 0.15% | <0.15% |
| Ether impurity | ≤ 0.15% | <0.15% |
| Lwm yam impurity | ≤0.10% | <0.10% |
| Tag nrho impurities | ≤0.50% | <0.50% |
| R-Enantiomer | ≤ 0.30% | <0.30% |
| Infrared Spectrum | Raws li tus qauv | Ua raws |
| 1 H NMR Spectrum | Raws li tus qauv | Ua raws |
| Xaus | Cov khoom tau raug kuaj thiab ua raws li USP35 Standard | |
Pob:Fluorinated Lub raj mis, Aluminium ntawv ci hnab, 25kg / Cardboard Nruas, lossis raws li cov neeg siv khoom xav tau.
Cia txias:Khaws lub thawv kaw kom nruj thiab khaws cia rau hauv qhov chaw txias, qhuav (2 ~ 8 ℃) thiab lub tsev tso cua txias kom deb ntawm cov khoom tsis sib xws.Tiv thaiv los ntawm lub teeb thiab noo noo.
Shipping:Xa mus thoob ntiaj teb los ntawm huab cua, los ntawm FedEx / DHL Express.Muab kev xa khoom sai thiab txhim khu kev qha.
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 muaj NLT 98.0% thiab NMT 102.0% ntawm cov ntawv sau npe ntawm C14H22N2O2·C4H6O6, xam rau ntawm lub hauv paus anhydrous.
IDENTIFICATION
• A. Infrared Absorption <197K>
• B. Lub sijhawm khaws cia ntawm lub ncov loj ntawm cov qauv kev daws teeb meem sib raug rau qhov System suitability solution, raws li tau txais hauv kev sim rau Organic Impurities, Txheej Txheem 2: Enantiomeric Purity.
QHIA
• Cov txheej txheem
Tsis muaj: 8.6 mg / mL ntawm monobasic ammonium phosphate.Kho nrog ammonia tov rau pH ntawm 7.0.
Mobile theem: Methanol, acetonitrile, thiab Buffer (15:15:70)
Kev daws teeb meem tsim nyog: 0.05 mg / mL txhua ntawm USP Rivastigmine Related Compound A RS thiab USP Rivastigmine Related Compound B RS hauv theem txawb
Kev daws teeb meem: 0.2 mg / mL ntawm USP Rivastigmine Tartrate RS nyob rau theem txawb
Cov qauv kev daws teeb meem: 0.2 mg / mL ntawm Rivastigmine Tartrate nyob rau theem txawb
Chromatographic system
(Saib Chromatography <621>, System Suitability.)
Qauv: LC
Detector: UV 215 nm
Kem: 4.6-mm × 25-cm;5-µm ntim L7
Tus nqi ntws: 1.2 mL / min
Kev txhaj tshuaj loj: 20 µL
[Ceeb toom-Tus nqi ntws yuav raug hloov mus rau 1.5 mL / min, yog tias xav tau, kom ua tiav lub sijhawm khaws cia ntawm rivastigmine txog li 10 min.]
Qhov system haum
Qauv: Kev daws teeb meem tsim nyog thiab kev daws teeb meem
Suitability xav tau
Kev daws teeb meem: NLT 1.5 nruab nrab ntawm rivastigmine ntsig txog compound A thiab rivastigmine ntsig txog compound B, Kev daws teeb meem tsim nyog
Kem efficiency: NLT 5000 theoretical daim hlau, Standard tov
Tailing yam: NMT 3.0, Standard tov
Tus txheeb ze tus qauv sib txawv: NMT 2.0%, Standard tov
Kev tsom xam
Qauv: Cov qauv kev daws teeb meem thiab cov qauv kev daws teeb meem
Xam cov feem pua ntawm C14H22N2O2·C4H6O6 hauv feem ntawm Rivastigmine Tartrate noj:
Result = (rU/rS) × (CS/CU) × 100
rU = ncov teb los ntawm Sample tov
rS = ncov teb los ntawm Standard tov
CS = concentration ntawm Standard tov (mg / mL)
CU = concentration of the Sample solution (mg/mL)
Kev lees paub: 98.0% -102.0% ntawm lub hauv paus anhydrous
IMPURITIES
Inorganic impurities
• Residue ntawm Ignition <281>: NMT 0.1%
• Heavy Metals, Method II <231>: NMT 20 ppm
Organic impurities
• Txheej txheem 1
Mobile theem thiab kev daws teeb meem tsim nyog: Ua raws li tau hais hauv Kev Tshawb Fawb.
Kev daws teeb meem: 1.0 µg / mL ntawm USP Rivastigmine Tartrate RS nyob rau theem txawb
Cov qauv tshuaj: 1.0 mg / mL ntawm Rivastigmine Tartrate nyob rau theem txawb
Chromatographic system: Ua raws li qhia hauv Kev Tshawb Fawb.
(Saib Chromatography <621>, System Suitability.)
Qhov system haum
Qauv: Kev daws teeb meem tsim nyog thiab kev daws teeb meem
Suitability xav tau
Kev daws teeb meem: NLT 1.5 nruab nrab ntawm rivastigmine ntsig txog compound A thiab rivastigmine ntsig txog compound B, Kev daws teeb meem tsim nyog
Tus txheeb ze tus qauv sib txawv: NMT 10%, Standard tov
Kev tsom xam [Ceeb toom-Lub sijhawm khiav yog 8 npaug ntawm lub sijhawm khaws cia ntawm rivastigmine ncov.]
Qauv: Cov qauv kev daws teeb meem thiab cov qauv kev daws teeb meem
Xam qhov feem pua ntawm ib tus neeg tsis huv hauv ib feem ntawm Rivastigmine Tartrate coj:
Result = (rU/rS) × (CS/CU) × (1/F) × 100
rU = ncov teb rau txhua impurity los ntawm cov qauv tov
rS = ncov teb los ntawm Standard tov
CS = concentration ntawm USP Rivastigmine Tartrate RS nyob rau hauv Standard tov (mg / mL)
CU = concentration ntawm Rivastigmine Tartrate nyob rau hauv cov qauv tov (mg / mL)
F = tus txheeb ze teb qhov tseem ceeb (saib Impurity Table 1)
Kev lees txais
Ib tug neeg impurities: Saib Impurity Table 1.
Tag nrho impurities: NMT 0.5%
Impurity Table 1
| Lub npe | Lub Sijhawm Retention Relative | Kwv tij teb Factor | Kev lees txais NMT % |
| Tartrate | 0.18 | — | Tsis quav ntsej |
| Phenol impurity | 0.28 ib | 1.6 | 0.3 |
| DPTAB | 0.46 ib | 0.83 ib | 0.15 |
| Tsis yog impurityc | 0.57 ib | 1.2 | 0.15 |
| Rivastigmine | 1.0 | 1.0 | — |
| Carbamate impurity | 4.1 | 1.3 | 0.15 |
| Ether impurity | 6.5 | 1.4 | 0.15 |
| Lwm yam impurity | — | 1.0 | 0.1 |
a (S)-3-[1-(Dimethylamino)ethyl]phenol.
b (+)-Di-(p-toluoyl)-d-tartaric acid (rivastigmine ntsig txog compound A).
c (S)-3-[1-(Dimethylamino)ethyl]phenyl dimethylcarbamate (rivastigmine ntsig txog compound B).
d 3-Nitrophenyl ethyl (methyl) carbamate.
e (S)-N,N-Dimethyl-1-[3-(4-nitrophenoxy)phenyl]ethanamine.
• Txheej txheem 2: Enantiomeric Purity
Tsis Siv Neeg: Hloov 1.78 g ntawm dibasic sodium phosphate dihydrate thiab 1.38 g ntawm monobasic sodium phosphate rau hauv 1000-mL ntim ntim.Dissolve nyob rau hauv thiab dilute nrog dej rau ntim.Kho nrog phosphoric acid rau pH ntawm 6.0.
Txawb theem: Hloov 20 mL ntawm acetonitrile thiab 205 µL ntawm N, N-dimethyloctylamine rau 1000-mL ntim ntim, thiab dilute nrog Buffer rau ntim.
Kev daws teeb meem: 0.1 µg / mL ntawm USP Rivastigmine Tartrate R-Isomer RS nyob rau theem txawb
Cov tshuaj rhiab heev: 0.05 µg / mL ntawm USP Rivastigmine Tartrate R-Isomer RS nyob rau theem Txawb, Standard tov
Kev daws teeb meem tsim nyog: 100 µg / mL ntawm USP Rivastigmine Tartrate RS thiab 0.1 µg / mL ntawm USP Rivastigmine Tartrate R-Isomer RS nyob rau theem txawb
Cov qauv kev daws teeb meem: 100 µg / mL ntawm Rivastigmine Tartrate nyob rau theem txawb
Chromatographic system
(Saib Chromatography <621>, System Suitability.)
Qauv: LC
Detector: UV 200 nm
Kem: 4.0-mm × 10-cm;kev L41
Tus nqi ntws: 0.5 mL / min
Kev txhaj tshuaj loj: 20 µL
Qhov system haum
Cov Qauv: Cov qauv kev daws teeb meem, kev daws teeb meem rhiab heev, thiab kev daws teeb meem tsim nyog
Suitability xav tau
Kev daws teeb meem: NLT 0.8 nruab nrab ntawm qhov siab tshaj enantiomer, Kev daws teeb meem tsim nyog
[Ceeb toom-Qhov kev txiav txim elution yog R-enantiomer, ua raws li rivastigmine ncov, uas yog S-enantiomer.]
Teeb liab-rau-lub suab piv: NLT 10, Kev daws teeb meem rhiab heev
Tus txheeb ze tus qauv sib txawv: NMT 10%, Standard tov
Kev tsom xam
Qauv: Cov qauv kev daws teeb meem thiab cov qauv kev daws teeb meem
Xam qhov feem pua ntawm R-enantiomer hauv feem ntawm Rivastigmine Tartrate noj:
Result = (rU/rS) × (CS/CU) × 100
rU = ncov teb ntawm R-enantiomer los ntawm cov qauv tov
rS = ncov teb ntawm R-enantiomer los ntawm Standard tov
CS = concentration ntawm R-enantiomer nyob rau hauv Standard tov (µg/mL)
CU = concentration ntawm Rivastigmine Tartrate nyob rau hauv cov qauv tov (µg/mL)
Kev lees txais: NMT 0.3% ntawm R-enantiomer
TSEEM CEEB
• Kev Txiav Txim Dej, Txoj Kev Ia <921>: NMT 0.5%
TSEEM CEEB
• Ntim thiab Cia: Khaws rau hauv cov thawv ntim nruj, thiab khaws cia hauv chav tsev kub.
• 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
Yuav Yuav Li Cas?Thov hu rauDr. Alvin Huang: sales@ruifuchem.com or alvin@ruifuchem.com
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Cov qauv?Cov khoom lag luam feem ntau muab cov qauv dawb rau kev soj ntsuam zoo, tus nqi thauj khoom yuav tsum tau them los ntawm cov neeg siv khoom.
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Kev thauj mus los?Los ntawm Express (FedEx, DHL), los ntawm Cua, los ntawm hiav txwv.
Cov ntaub ntawv?Kev pab cuam tom qab muag: COA, MOA, ROS, MSDS, thiab lwm yam tuaj yeem muab tau.
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UN IDs UN 2811 6.1 / PGII
WGK Germany 3
RTECS FA9550000
HS Code 29242990
Hazard Chav Kawm 6.1
Packing Group III
Rivastigmine Tartrate (CAS: 129101-54-8) yog tartrate ntawm rivastigmine, tshuaj kho mob Alzheimer's disease.Rivastigmine yog physostigmine derivative, uas tau ua tiav thawj zaug los ntawm Novartis, Switzerland.Lub npe lag luam yog exelon, thiab cov molecule muaj cov qauv benzyl carbamate, nws yog carbamate lub hlwb xaiv cholinesterase inhibitor, uas tuaj yeem cuam tshuam acetylcholinesterase thiab butyrylcholinesterase tib lub sijhawm, thiab txhawb cholinergic paj hlwb los ntawm kev ncua kev degradation ntawm acetylcholineic tso tawm. neurons.Nws tuaj yeem txhim kho qhov kev paub tsis meej ntawm kev sib kho los ntawm cholinergic, yog li txhim kho kev paub txog cov neeg mob Alzheimer's disease.Lub plasma protein binding muaj peev xwm ntawm rivastigmine yog qhov tsis muaj zog, yooj yim dhau los ntawm cov hlab ntsha-hlwb barrier, thiab muaj cov qib siab ntawm lub hlwb xaiv.Nws tuaj yeem tsis tsuas yog xaiv los ntawm thaj chaw uas muaj kev cuam tshuam ntau tshaj plaws ntawm lub paj hlwb thiab hippocampus, tab sis kuj tseem nyiam inhibit qhov tseem ceeb ntawm AChE hauv lub hlwb, uas tuaj yeem txo qis peripheral cholinergic phiv thaum tsim kho cov teebmeem.Ib nrab-lub neej ntawm rivastigmine tartrate hauv lub cev yog luv thiab lub sijhawm ua haujlwm ntev.Tsis zoo li tacrine, cov khoom no muaj zog inhibitory nyhuv ntawm G1 enzyme nyob rau hauv lub hippocampus thiab cortex.Nws yog siv los kho mob me me mus rau nruab nrab Alzheimer's dementia, uas xav tias yog Alzheimer's disease lossis Alzheimer's disease.
1. Raws li ib qho acetylcholinesterase inhibitor, rivastigmine bicartrate tuaj yeem txhim kho cov nyhuv ntawm succinylcholine nqaij relaxant.Yog li ntawd, yuav tsum muaj ib lub sij hawm luv luv kom tsis txhob noj cov khoom no ua ntej tshuaj loog.Cov khoom no yuav tsum tau ua ke nrog lwm cov tshuaj cholinergic lossis anticholinergic, thiab yuav tsum tau ceev faj (saib [Drug Interaction]).
2. Vim lawv cov tshuaj pharmacological, cholinesterase inhibitors tuaj yeem ua rau lub paj hlwb tsis zoo rau lub plawv dhia.Raws li nrog rau lwm yam tshuaj cholinergic, yuav tsum tau ceev faj thaum muab rau cov neeg mob uas muaj mob sinus syndrome los yog lwm yam mob plawv (saib Cov Kev Phem Tsis Zoo).
3. Cholinergic paj excitement tuaj yeem ua rau muaj zog gastric acid secretion.Txawm hais tias tsis muaj pov thawj ntawm kev cuam tshuam loj ntawm cov tsos mob tshwm sim thaum lub sij hawm soj ntsuam, cov neeg mob uas muaj feem yuav mob plab, xws li cov neeg muaj keeb kwm ntawm cov kab mob rwj lossis cov neeg tau txais kev kho mob nrog cov tshuaj uas tsis yog-steroidal anti-inflammatory, yuav tsum tau siv nrog ceev faj.
4. Zoo li lwm yam cholinesterase inhibitors, cov neeg mob uas muaj keeb kwm ntawm mob hawb pob lossis lwm yam kab mob pulmonary yuav tsum tau siv nrog ceev faj.
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