Rivastigmine Tartrate CAS 129101-54-8 Assay 98.0~102.0
I-Shanghai Ruifu Chemical Co., Ltd. ngumenzi ohamba phambili weRivastigmine Tartrate (CAS: 129101-54-8) enomgangatho ophezulu.I-Ruifu Chemical inokubonelela ngenkonzo yehlabathi jikelele, ixabiso elikhuphisanayo, inkonzo egqwesileyo, encinci kunye nezixa ezininzi ezikhoyo.Thenga iRivastigmine Tartrate,Please contact: alvin@ruifuchem.com
| Igama leMchiza | I-Rivastigmine Tartrate |
| Izithethantonye | i-Exelon;ENA-713;Rivastigmine L-Tartrate;Rivastigmine Hydrogen Tartrate;I-CS-118;I-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 |
| Ubume beStokhwe | Kwi-Stock, iMveliso yoRhwebo |
| Inombolo yeCAS | 129101-54-8 |
| CAS ezinxulumene | 123441-03-2 |
| Ifomula yeemolekyuli | C14H22N2O2·C4H6O6 |
| Ubunzima beMolekyuli | 400.43 g/mol |
| Indawo yokunyibilika | 124.0 ukuba 128.0℃ |
| Ujikelezo oluKhethekileyo [a]20/D | +4.0 ° ukuya +7.0 ° (C=5, Methanol) |
| Ukunyibilika | Inyibilika kwiMethanol |
| I-COA kunye ne-MSDS | Iyafumaneka |
| Imvelaphi | Shanghai, China |
| Uphawu | Ruifu Chemical |
| Izinto | ImiGangatho yokuHlola | Iziphumo |
| Imbonakalo | Mhlophe ukuya kuMhlophe oMhlophe wePowder | Iyahambelana |
| Isivavanyi | 98.0 ~ 102.0% (kwisiseko seAnhydrous) | 99.8% |
| Amanzi nguKarl Fischer | ≤0.50% | 0.15% |
| Intsalela kwi-Ignition | ≤0.10% | 0.07% |
| Iintsimbi ezinzima (Pb) | ≤20ppm | <10ppm |
| Ukungacoceki kwePhenol | ≤0.30% | <0.30% |
| DPTTA | ≤0.15% | <0.15% |
| Okanye Ukungcola | ≤0.15% | <0.15% |
| Ukungacoceki kweCarbamate | ≤0.15% | <0.15% |
| Ukungacoceki kwe-Etere | ≤0.15% | <0.15% |
| Nakuphi na Okunye Ukungcola | ≤0.10% | <0.10% |
| Ukungcola okupheleleyo | ≤0.50% | <0.50% |
| R-Enantiomer | ≤0.30% | <0.30% |
| I-Infrared Spectrum | Ngokungqinelana noLwakhiwo | Iyahambelana |
| I-1H NMR Spectrum | Ngokungqinelana noLwakhiwo | Iyahambelana |
| Ukuqukumbela | Imveliso ivavanyiwe kwaye ihambelana ne-USP35 Standard | |
Umqulu:Ibhotile eFluorinated, iAluminium foil bag, 25kg/Cardboard Drum, okanye ngokwemfuno yomthengi.
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I-Rivastigmine Tartrate
C14H22N2O2·C4H6O6 400.42
I-Ethylmethylcarbamic acid, 3 - [(S) -1- (dimethylamino) ethyl] phenyl ester, (2R, 3R) -2,3-dihydroxybutanedioate;
(S) -3- [1- (Dimethylamino) ethyl] phenyl ethylmethylcarbamate, i-hydrogen tartrate [129101-54-8].
I-Rivastigmine 250.34 [123441-03-2].
INGCACISO
I-Rivastigmine Tartrate iqulethe i-NLT 98.0% kunye ne-NMT 102.0% yemali ebhaliweyo ye-C14H22N2O2·C4H6O6, ibalwe ngokwesiseko se-anhydrous.
UKUCHAZA
• A. I-Infrared Absorption <197K>
• B. Ixesha lokugcinwa kwencopho enkulu yeSampuli yesisombululo ihambelana neso sisombululo sokufaneleka kweSistim, njengoko kufunyenwe kuvavanyo lwe-Organic Impurities, iNkqubo yesi-2: i-Enantiomeric Purity.
UVAVANYO
• Inkqubo
Isithinteli: 8.6 mg/mL ye monobasic ammonium phosphate.Lungisa isisombululo se-ammonia kwi-pH ye-7.0.
Inqanaba leselula: Methanol, acetonitrile, kunye neBuffer (15:15:70)
Isisombululo sokufaneleka kwenkqubo: 0.05 mg / mL nganye ye-USP Rivastigmine eNxulumene neCompound A RS kunye ne-USP Rivastigmine eNxulumene neCompound B RS kwisigaba seMobile
Isisombululo esisemgangathweni: 0.2 mg / mL ye-USP Rivastigmine Tartrate RS kwisigaba seMobile
Isisombululo sesampuli: 0.2 mg / mL yeRivastigmine Tartrate kwisigaba seMobile
Inkqubo yeChromatographic
(Jonga iChromatography <621>, Ukufaneleka kweNkqubo.)
Indlela: LC
Umtshina: UV 215 nm
Ikholomu: 4.6-mm × 25-cm;5-µm ukupakisha i-L7
Izinga lokuhamba: 1.2 mL / min
Ubungakanani betofu: 20 µL
[Qaphela-Isantya sokuhamba singalungiswa kwi-1.5 mL / min, ukuba kuyimfuneko, ukufezekisa ixesha elicetyiswayo lokugcinwa kwe-rivastigmine malunga ne-10 min.]
Ukufaneleka kwenkqubo
Iisampulu: Isisombululo sokufaneleka kwenkqubo kunye nesisombululo esiPhakathi
Iimfuno zokufaneleka
Isisombululo: NLT 1.5 phakathi kwe-rivastigmine enxulumene nekhompawundi A kunye ne-rivastigmine enxulumene nekhompawundi B, isisombululo sokufaneleka kweNkqubo
Ukusebenza kwekholomu: I-NLT 5000 iipleyiti zethiyori, isisombululo esisemgangathweni
Umba wokutsala: NMT 3.0, isisombululo esisemgangathweni
Ukutenxa komgangatho ozalanayo: NMT 2.0%, isisombululo esisemgangathweni
Uhlalutyo
Iisampulu: Isisombululo esisemgangathweni kunye nesisombululo seSampuli
Bala ipesenti ye-C14H22N2O2 · C4H6O6 kwisahlulo seRivastigmine Tartrate ethathiweyo:
Isiphumo = (rU/rS) × (CS/CU) × 100
rU = impendulo ephezulu evela kwiSampuli yesisombululo
rS = impendulo ephezulu evela kwisisombululo esiPhakathi
CS = ugxininiso lwesisombululo esiPhakathi (mg/mL)
CU = ukuxinana kweSampuli yesisombululo (mg/mL)
Indlela yokwamkela: 98.0% -102.0% kwisiseko se-anhydrous
UBUNGCOLA
Ukungcola Kwezinto Eziphilayo
• Intsalela ekuZisweni <281>: NMT 0.1%
• Iintsimbi ezinzima, Indlela II <231>: NMT 20 ppm
Ukungcola Okuphilayo
• Inkqubo 1
Isigaba seselula kunye nesisombululo sokufaneleka kweSistim: Qhubeka njengoko kuyalelwe kwi-Assay.
Isisombululo esisemgangathweni: 1.0 µg/mL ye USP Rivastigmine Tartrate RS kwisigaba seMobile
Isisombululo sesampuli: 1.0 mg / mL yeRivastigmine Tartrate kwisigaba seMobile
Inkqubo yeChromatographic: Qhubeka njengoko kuyalelwe kwi-Assay.
(Jonga iChromatography <621>, Ukufaneleka kweNkqubo.)
Ukufaneleka kwenkqubo
Iisampulu: Isisombululo sokufaneleka kwenkqubo kunye nesisombululo esiPhakathi
Iimfuno zokufaneleka
Isisombululo: NLT 1.5 phakathi kwe-rivastigmine enxulumene nekhompawundi A kunye ne-rivastigmine enxulumene nekhompawundi B, isisombululo sokufaneleka kweNkqubo
Ukutenxa komgangatho ozalanayo: NMT 10%, isisombululo esisemgangathweni
Uhlalutyo [Qaphela-Ixesha lokuqhuba ngamaxesha e-8 ixesha lokugcinwa kwe-rivastigmine peak.]
Iisampulu: Isisombululo esisemgangathweni kunye nesisombululo seSampuli
Bala ipesenti yakho nakuphi na ukungcola komntu kwinxalenye yeRivastigmine Tartrate ethathiweyo:
Isiphumo = (rU/rS) × (CS/CU) × (1/F) × 100
i-rU = impendulo ephezulu yokungcola ngalunye kwisisombululo seSampuli
rS = impendulo ephezulu evela kwisisombululo esiPhakathi
CS = ukuxinwa kwe-USP Rivastigmine Tartrate RS kwisisombululo esiPhakathi (mg / mL)
I-CU = i-concentration ye-Rivastigmine Tartrate kwi-Sample solution (mg / mL)
F = isalamane sempendulo (jonga iTheyibhile yoku-1)
Iinqobo zokwamkelwa
Ukungcola komntu ngamnye: Jonga iTheyibhile yoku-1 yokungacoceki.
Ubumdaka bubonke: NMT 0.5%
Itheyibhile yokungcola 1
| Igama | Ixesha lokuGcina isihlobo | Isinxulumani seMpendulo Factor | Iinqobo zokwamkelwa kwe-NMT % |
| Tartrate | 0.18 | - | Ukungahoyi |
| Phenol impuritya | 0.28 | 1.6 | 0.3 |
| DPTTAb | 0.46 | 0.83 | 0.15 |
| Okanye ukungcola | 0.57 | 1.2 | 0.15 |
| Rivastigmine | 1.0 | 1.0 | - |
| Carbamate ukungcola | 4.1 | 1.3 | 0.15 |
| I-Ether engahlambulukanga | 6.5 | 1.4 | 0.15 |
| Nakuphi na okunye ukungcola | - | 1.0 | 0.1 |
a (S) -3-[1-(Dimethylamino)ethyl]phenol.
b (+)-Di-(p-toluoyl)-d-tartaric acid (ikhompawundi enxulumene ne-rivastigmine A).
c (S) -3- [1- (Dimethylamino) ethyl] phenyl dimethylcarbamate (i-rivastigmine enxulumene nekhompawundi B).
d 3-Nitrophenyl ethyl(methyl)carbamate.
e (S)-N,N-Dimethyl-1-[3-(4-nitrophenoxy)phenyl]ethanamine.
• Inkqubo yesi-2: I-Enantiomeric Purity
I-Buffer: Dlulisa i-1.78 g ye-dibasic sodium phosphate dihydrate kunye ne-1.38 g ye-monobasic sodium phosphate kwi-flask ye-volumetric ye-1000-mL.Dissolve kwaye uhlambulule ngamanzi ukuya kwivolumu.Lungisa nge-asidi ye-phosphoric ukuya kwi-pH ye-6.0.
Isigaba seMobile: Ukutshintshela i-20 mL ye-acetonitrile kunye ne-205 µL ye-N,N-dimethyloctylamine ukuya kwi-1000-mL yeflask yevolumetric, kwaye uhlambulule nge-Buffer ukuya kwivolumu.
Isisombululo esisemgangathweni: 0.1 µg/mL ye-USP Rivastigmine Tartrate R-Isomer RS kwisigaba seMobile
Isisombululo se-Sensitivity: 0.05 µg/mL ye-USP Rivastigmine Tartrate R-Isomer RS kwisigaba seMobile, isisombululo esisemgangathweni
Isisombululo sokufaneleka kwenkqubo: 100 µg/mL ye-USP Rivastigmine Tartrate RS kunye ne-0.1 µg/mL ye-USP Rivastigmine Tartrate R-Isomer RS kwisigaba seMobile
Isisombululo sesampuli: 100 µg/mL yeRivastigmine Tartrate kwisigaba seMobile
Inkqubo yeChromatographic
(Jonga iChromatography <621>, Ukufaneleka kweNkqubo.)
Indlela: LC
Umtshina: UV 200 nm
Ikholamu: 4.0-mm × 10-cm;ukupakisha L41
Izinga lokuhamba: 0.5 mL / min
Ubungakanani betofu: 20 µL
Ukufaneleka kwenkqubo
Iisampulu: Isisombululo esisemgangathweni, isisombululo seSensitivity, kunye nesisombululo sokufaneleka kweNkqubo
Iimfuno zokufaneleka
Isisombululo: I-NLT 0.8 phakathi kweencopho ze-enantiomer, isisombululo sokufaneleka kweNkqubo
[Qaphela-Umyalelo we-elution yi-R-enantiomer, ilandelwa yincopho ye-rivastigmine, eyi-S-enantiomer.]
Umlinganiselo we-Signal-to-noise: NLT 10, isisombululo se-Sensitivity
Ukutenxa komgangatho ozalanayo: NMT 10%, isisombululo esisemgangathweni
Uhlalutyo
Iisampulu: Isisombululo esisemgangathweni kunye nesisombululo seSampuli
Bala ipesenti ye-R-enantiomer kwisahlulo seRivastigmine Tartrate ethathiweyo:
Isiphumo = (rU/rS) × (CS/CU) × 100
I-rU = impendulo ephezulu ye-R-enantiomer kwisisombululo seSampuli
rS = impendulo ephezulu ye-R-enantiomer ukusuka kwisisombululo esiPhakathi
CS = ugxininiso lwe-R-enantiomer kwisisombululo esiPhakathi (µg/mL)
I-CU = i-concentration ye-Rivastigmine Tartrate kwi-Sample solution (µg/mL)
Indlela yokwamkela: NMT 0.3% ye-R-enantiomer
IIMVAVANYO EZITHILE
• Ukumiselwa kwaManzi, Indlela i-Ia <921>: NMT 0.5%
IIMFUNO EZONGEZELELWEYO
• Ukupakisha Nokugcina: Zigcine kwizikhongozeli eziqinileyo, uze uzigcine kwindawo yobushushu begumbi.
• IMigangatho yeReferensi ye-USP <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
Ukuthenga njani?Nceda uqhagamshelaneDr. Alvin Huang: sales@ruifuchem.com or alvin@ruifuchem.com
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Ii-ID ze-UN UN 2811 6.1 / PGII
WGK eJamani 3
RTECS FA9550000
Ikhowudi yeHS 29242990
Udidi lweengozi 6.1
Ukupakisha Iqela III
I-Rivastigmine Tartrate (i-CAS: i-129101-54-8) yi-tartrate ye-rivastigmine, ichiza lonyango lwe-Alzheimer's disease.I-Rivastigmine yi-physostigmine derivative, eyaphuhliswa ngempumelelo okokuqala nguNovartis, eSwitzerland.Igama lokurhweba yi-exelon, kwaye i-molecule inesakhiwo se-benzyl carbamate, i-carbamate brain-selective cholinesterase inhibitor, enokuthintela i-acetylcholinesterase kunye ne-butyrylcholinesterase ngexesha elifanayo, kwaye ikhuthaze i-cholinergic nerve conduction ngokulibazisa ukuthotywa kwe-acetylcholine ekhutshwe yi-cholinergic. imithambo-luvo.Inokuphucula ukungasebenzi kwengqondo edibeneyo yi-cholinergic, ngaloo ndlela iphucula umphumo wengqondo wezigulane ezine-Alzheimer's disease.Iprotheyini yeplasma yokubopha amandla e-rivastigmine ibuthathaka, kulula ukudlula kwisithintelo segazi-ingqondo, kwaye inomlinganiselo ophezulu wokukhethwa kwengqondo.Ayinakwenza ngokukhethayo kuphela kwezona ndawo zisemngciphekweni we-cerebral cortex kunye ne-hippocampus, kodwa ikwanqanda ngokukhethekileyo ii-subtypes eziphambili ze-AChE ebuchosheni, ezinokunciphisa iziphumo ebezingalindelekanga ze-cholinergic ngelixa ivelisa iziphumo zonyango.Ubomi besiqingatha se-rivastigmine tartrate emzimbeni bufutshane kwaye ixesha lesenzo lide.Ngokungafaniyo ne-tacrine, le mveliso inempembelelo enamandla yokuthintela kwi-enzyme ye-G1 kwi-hippocampus kunye ne-cortex.Isetyenziswa eklinikhi ukunyanga i-Alzheimer's dementia ephakathi ukuya kwephakathi, ekurhaneleka ukuba sisifo sika-Alzheimer okanye isifo sika-Alzheimer.
1. Njenge-acetylcholinesterase inhibitor, i-rivastigmine bicartrate inokuphucula umphumo we-succinylcholine muscle relaxant.Ngoko ke, kufuneka kubekho ixesha elifanelekileyo lokuyeka ukuthatha le mveliso phambi kwe-anesthesia.Le mveliso kufuneka idibaniswe namanye amalungiselelo e-cholinergic okanye i-anticholinergic, kwaye isilumkiso kufuneka sithathwe (jonga [i-Drug Interaction]).
2. Ngenxa yeempembelelo zabo ze-pharmacological, i-cholinesterase inhibitors ingaba nemiphumo ye-vagus nerve tension kwizinga lentliziyo.Njengakwamanye amachiza e-cholinergic, kufuneka kulumke xa kunikwa izigulane ezine-sinus syndrome ezigulayo okanye enye ibhloko yentliziyo (jonga i-Actions Rections).
3. I-Cholinergic nerve excitement inokubangela ukwanda kwe-asidi yesisu.Nangona kungekho bungqina bokuwohloka okuphawulekayo kweempawu ezihambelanayo ezifunyenweyo ngexesha lovavanyo lweklinikhi, izigulane ezinomngcipheko ophezulu wezilonda zesisu, ezifana nezo zinembali yesifo sesilonda okanye abo bafumana unyango oluhambelanayo kunye neziyobisi ezingekho-steroidal ezichasayo, kufuneka isetyenziswe ngononophelo.
4. Njengezinye i-cholinesterase inhibitors, izigulane ezinembali ye-asthma okanye ezinye izifo ze-pulmonary obstructive kufuneka zisetyenziswe ngokuqaphela.
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