Rivastigmine Tartrate CAS 129101-54-8 Assay 98.0 ~ 102.0
Shanghai Ruifu Chemical Co., Ltd. waa saaraha ugu horreeya ee Rivastigmine Tartrate (CAS: 129101-54-8) oo leh tayo sare.Kiimikada Ruifu waxay bixin kartaa gaarsiinta adduunka oo dhan, qiimo tartan ah, adeeg aad u wanaagsan, tiro yar iyo tiro badan oo la heli karo.Iibso Rivastigmine Tartrate,Please contact: alvin@ruifuchem.com
Magaca Kiimikada | Rivastigmine Tartrate |
La mid ah | 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 |
Heerka Saamiyada | Suuqa dhexdiisa, Wax-soo-saarka Ganacsiga |
Lambarka CAS | 129101-54-8 |
CAS la xidhiidha | 123441-03-2 |
Qaanuunka molecular | C14H22N2O2·C4H6O6 |
Miisaanka Molecular | 400.43 g/mol |
Meesha dhalaalaysa | 124.0 ilaa 128.0 ℃ |
Wareeg gaar ah [a]20/D | +4.0° ilaa +7.0° (C=5, methanol) |
Solubility | Ku milma Methanol |
COA & MSDS | La heli karo |
Asal ahaan | Shanghai, Shiinaha |
Summada | Kiimikada Ruifu |
Walxaha | Heerarka Kormeerka | Natiijooyinka |
Muuqashada | Budada Crystalline ee Caddaan iyo Off-White | U hogaansama |
Qiimayn | 98.0 ~ 102.0% (oo ku salaysan Anhydrous) | 99.8% |
Biyaha waxaa qoray Karl Fischer | ≤0.50% | 0.15% |
Hadhaaga dabka | ≤0.10% | 0.07% |
Biraha culus (Pb) | ≤20pm | <10pm |
phenol wasakh | ≤0.30% | <0.30% |
DPTTA | ≤0.15% | <0.15% |
Midna wasakhnimo | ≤0.15% | <0.15% |
Carbamate wasakh | ≤0.15% | <0.15% |
Ether wasakh | ≤0.15% | <0.15% |
Wax kasta oo wasakh kale ah | ≤0.10% | <0.10% |
Wadarta wasakhda | ≤0.50% | <0.50% |
R-Enantiomer | ≤0.30% | <0.30% |
Infrared Spectrum | Waafaqsan Qaab-dhismeedka | U hogaansama |
1H NMR Spectrum | Waafaqsan Qaab-dhismeedka | U hogaansama |
Gabagabo | Alaabta waa la tijaabiyay oo waafaqday heerka USP35 |
Xidhmada:Dhalada fluorinated, bacda bireed aluminium, 25kg/Drum kartoonada, ama sida waafaqsan shuruudaha macmiilka.
Xaaladda Kaydinta:Weelka si adag u xidh oo ku kaydi qabow, qalalan (2 ~ 8 ℃) iyo bakhaar hawo wanaagsan leh oo ka fog walxaha aan ku habboonayn.Ka ilaali iftiinka iyo qoyaanka.
Rarida:Ku gaarsii adduunka oo dhan hawo, by FedEx/DHL Express.Bixi keenid degdeg ah oo la isku halayn karo.
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].
Qeexitaan
Rivastigmine Tartrate waxay ka kooban tahay NLT 98.0% iyo NMT 102.0% ee cadadka la calaamadeeyay ee C14H22N2O2 · C4H6O6, oo lagu xisaabiyay ku salaysan anhydrous.
AQOONSIGA
• A. Nuugista Infrared <197K>
B. Waqtiga haynta ee ugu sarraysa ee xalka Tusaalaha waxay u dhigantaa tan habka ku habboonaanta nidaamka, sida lagu helay tijaabada wasakhaynta dabiiciga ah, Habka 2: Nadiifinta Enantiomeric.
ASSAY
Habka
Bakhaar: 8.6 mg/mL oo ah ammonium fosfooraska monobasic.Ku hagaaji xalka ammonia pH 7.0.
Marxaladda mobilada: Methanol, acetonitrile, iyo Buffer (15:15:70)
Xalka ku habboonaanta nidaamka: 0.05 mg/mL mid kasta oo ka mid ah USP Rivastigmine Combound A RS iyo USP Rivastigmine La Xiriira Isku-dhafka B RS ee wajiga mobaylka
Xalka caadiga ah: 0.2 mg/mL ee USP Rivastigmine Tartrate RS ee wajiga mobilada
Xalka muunada: 0.2 mg/mL ee Rivastigmine Tartrate ee wajiga mobaylka
Nidaamka Chromatographic
(Fiiri Chromatography <621>, Habboonaanta Nidaamka.)
Habka: LC
Baaraha: UV 215 nm
Tiirka: 4.6-mm × 25-cm;5-µm xirmo L7
Heerka socodka: 1.2 ml/min
Cabbirka duritaanka: 20 µL
[Xusuusin-Heerka socodka waxaa lagu hagaajin karaa 1.5 mL/daqiiqo, haddii loo baahdo, si loo gaaro waqti lagu taliyey oo lagu hayo rivastigmine qiyaastii 10 min.]
Ku habboonaanta nidaamka
Tusaalooyinka: Xalka ku habboonaanta nidaamka iyo xalalka caadiga ah
Shuruudaha ku habboonaanta
Xallinta: NLT 1.5 inta u dhaxaysa xayndaabka laxiriira rivastigmine A iyo walaxda laxidhiidha rivastigmine, Xalka ku haboonaanta nidaamka
Waxtarka tiirka: NLT 5000 taarikada aragtida, xalalka caadiga ah
Qodobka dabada: NMT 3.0, Xalka caadiga ah
Isbeddel heerka qaraabada ah: NMT 2.0%, Xalka caadiga ah
Falanqaynta
Tusaalooyinka: Xalka caadiga ah iyo xalalka muunada
Xisaabi boqolkiiba C14H22N2O2·C4H6O6 ee qaybta Rivastigmine Tartrate ee la qaatay:
Natiijadu = (rU/rS) × (CS/CU) × 100
rU = jawaabta ugu sarreysa ee xalka Tusaalaha
rS = jawaabta ugu sarreysa ee xalalka caadiga ah
CS = fiirsashada xalalka caadiga ah (mg/mL)
CU = fiirsashada saamiga saamiga (mg/mL)
Shuruudaha aqbalaadda: 98.0% -102.0% ku salaysan anhydrous
XANUUNKA
wasakhda aan noolaha ahayn
• Hadhaaga dabka <281>: NMT 0.1%
• Biraha culus, Habka II <231>: NMT 20 ppm
Waxyeellada dabiiciga ah
Habka 1
Marxaladda wareegta iyo xalka ku habboonaanta nidaamka: U wad sida lagu faray Imtixaanka.
Xalka caadiga ah: 1.0 µg/ml ee USP Rivastigmine Tartrate RS ee wajiga mobaylka
Xalka muunada: 1.0 mg/mL ee Rivastigmine Tartrate ee wajiga mobaylka
Nidaamka Chromatographic: U wad sida lagu faray Assay.
(Fiiri Chromatography <621>, Habboonaanta Nidaamka.)
Ku habboonaanta nidaamka
Tusaalooyinka: Xalka ku habboonaanta nidaamka iyo xalalka caadiga ah
Shuruudaha ku habboonaanta
Xallinta: NLT 1.5 inta u dhaxaysa xayndaabka laxiriira rivastigmine A iyo walaxda laxidhiidha rivastigmine, Xalka ku haboonaanta nidaamka
Isbeddelka heerka qaraabada: NMT 10%, Xalka caadiga ah
Falanqaynta [Xusuusin-Waqtiga orodku waa 8 jeer wakhtiga haynta ee ugu sarreysa rivastigmine.]
Tusaalooyinka: Xalka caadiga ah iyo xalalka muunada
Xisaabi boqolleyda wasakh kasta oo shakhsi ah ee qaybta Rivastigmine Tartrate ee la qaatay:
Natiijadu = (rU/rS) × (CS/CU) × (1/F) × 100
rU = jawaabta ugu sarraysa ee wasakh kasta oo ka timid xalka Tusaalaha
rS = jawaabta ugu sarreysa ee xalalka caadiga ah
CS = fiirsashada USP Rivastigmine Tartrate RS ee xalka caadiga ah (mg/mL)
CU = fiirsashada Rivastigmine Tartrate ee xalka muunada (mg/mL)
F = qodobka jawaab celinta qaraabo (eeg Jadwalka wasakhda 1)
Shuruudaha aqbalaadda
Wasakhda Shakhsiyeed: Eeg Shaxda 1aad ee wasakhda.
Wadarta wasakhda: NMT 0.5%
Shaxda wasakhaysan 1
Magaca | Waqtiga Haynta Qaraabo | Qodobka Jawaabcelinta Qaraabo | Shuruudaha Ogolaanshaha NMT % |
Tartrate | 0.18 | - | Iska daa |
phenol wasakh | 0.28 | 1.6 | 0.3 |
DPTTAB | 0.46 | 0.83 | 0.15 |
Mid aan nadiif ahayn | 0.57 | 1.2 | 0.15 |
Rivastigmine | 1.0 | 1.0 | - |
Carbamate nijaasaysan | 4.1 | 1.3 | 0.15 |
Ether wasakh | 6.5 | 1.4 | 0.15 |
Wax kasta oo wasakh kale ah | - | 1.0 | 0.1 |
a (S)-3-[1- (Dimethylamino) ethyl] phenol.
b (+)-Di-(p-toluoyl) -d-tartaric acid (koox laxiriira rivastigmine A).
c (S) -3- [1- (Dimethylamino) ethyl] phenyl dimethylcarbamate (rivastigmine oo la xiriirta B).
d 3-Nitrofenyl ethyl(methyl)carbamate.
e (S) -N, N-Dimethyl-1-[3- (4-nitrophenoxy) phenyl] etanamine.
Habka 2: Nadiifinta Enantiomeric
Buffer: Ku wareeji 1.78 g oo ah dihydrate sodium phosphate dihydrate iyo 1.38 g oo ah monobasic sodium fosfate, geli 1000-mL weel mug leh.Ku milmi oo ku mil biyo ilaa mugga.Ku hagaaji aashitada fosfooraska ilaa pH 6.0.
Marxaladda mobilada: Ku wareeji 20 mL oo acetonitrile ah iyo 205 µL ee N,N-dimethylotylamine ilaa 1000-mL weel mug leh, oo ku milmi Buffer ilaa mugga.
Xalka caadiga ah: 0.1 µg/ml ee USP Rivastigmine Tartrate R-Isomer RS ee marxaladda mobilada
Xalka xasaasiga ah: 0.05 µg/ml ee USP Rivastigmine Tartrate R-Isomer RS ee wajiga mobaylka, xalalka caadiga ah
Xalka ku habboonaanta nidaamka: 100 µg/ml ee USP Rivastigmine Tartrate RS iyo 0.1 µg/mL ee USP Rivastigmine Tartrate R-Isomer RS ee wejiga mobilada
Tusaalaha xalalka: 100 µg/ml ee Rivastigmine Tartrate ee wajiga mobaylka
Nidaamka Chromatographic
(Fiiri Chromatography <621>, Habboonaanta Nidaamka.)
Habka: LC
Baaraha: UV 200 nm
Tiirka: 4.0-mm × 10-cm;xirxiran L41
Heerka socodka: 0.5 ml/min
Cabbirka duritaanka: 20 µL
Ku habboonaanta nidaamka
Tusaalooyinka: Xalka caadiga ah, Xalka xasaasiga ah, iyo xalka ku habboonaanta nidaamka
Shuruudaha ku habboonaanta
Qaraarka: NLT 0.8 inta u dhaxaysa eantiomer ugu sarreeya, Xalka ku habboonaanta nidaamka
[Fiiro gaar ah-Amarka sare-u-qaadista waa R-enantiomer, oo ay ku xigto meesha ugu sarreysa ee rivastigmine, oo ah S-enantiomer.]
Saamiga calaamad-ilaa-sanqa: NLT 10, Xalka xasaasiga ah
Isbeddelka heerka qaraabada: NMT 10%, Xalka caadiga ah
Falanqaynta
Tusaalooyinka: Xalka caadiga ah iyo xalalka muunada
Xisaabi boqolkiiba R-enantiomer ee qaybta Rivastigmine Tartrate ee la qaatay:
Natiijadu = (rU/rS) × (CS/CU) × 100
rU = jawaabta ugu sarreysa ee R-enantiomer ee xalka Tusaalaha
rS = jawaabta ugu sarreysa ee R-enantiomer ee xalalka caadiga ah
CS = uruurinta R-enantiomer ee xalka caadiga ah (µg/mL)
CU = fiirsashada Rivastigmine Tartrate ee xalka Tusaalaha (µg/ml)
Shuruudaha aqbalaadda: NMT 0.3% ee R-enantiomer
IMTIXAANO GAAR AH
• Go'aaminta Biyaha, Habka IA <921>: NMT 0.5%
SHURUUD DHEERAAD AH
Baakadaha iyo Kaydinta: Ku kaydi weelal cidhiidhi ah, kuna kaydi heerkulka qolka.
• Heerarka Tixraaca USP <11>
USP Rivastigmine Tartrate RS
Isku dhafka USP Rivastigmine ee La Xiriira A RS
Di-p-toluoyl-d-(+)-tartaric acid monohydrate.
C20H20O9 404.37
Isku dhafka USP Rivastigmine ee la xidhiidha 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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Kooxda Baakadaha III
Rivastigmine Tartrate (CAS: 129101-54-8) waa tartrate of rivastigmine, daawo loogu talagalay daawaynta cudurka Alzheimers.Rivastigmine waa derivative physostigmine, kaas oo si guul leh u sameeyay markii ugu horeysay Novartis, Switzerland.Magaca ganacsigu waa exelon, molecule-kuna wuxuu leeyahay qaab-dhismeedka carbamate benzyl, waa carbamate maskaxda-doorashada cholinesterase inhibitor, kaas oo joojin kara acetylcholinesterase iyo butyrylcholinesterase isku mar, iyo kor u qaadida habdhiska dareenka cholinergic by dib u dhigista hoos u dhaca acetylcholine sii daayo cholinergic. neuronsWaxay hagaajin kartaa cilladda garashada ee ay dhexdhexaadinayso cholinergic, taas oo hagaajinaysa saameynta garashada ee bukaannada qaba cudurka Alzheimers.Awoodda isku xidhka borotiinka balaasmaha ee rivastigmine waa daciif, way fududahay in la dhex maro xannibaadda maskaxda-maskaxda, waxayna leedahay heer sare oo xulashada maskaxda.Ma aha oo kaliya in ay si xushmad leh u dhaqdo meelaha ugu nugul ee kortex maskaxda iyo hippocampus, laakiin sidoo kale waxay si gaar ah u joojin kartaa noocyada hoose ee AChE ee maskaxda, taas oo yareyn karta saameynaha cholinergic ee durugsan iyada oo soo saarta saameynaha daaweynta.Nolosha nuska ah ee rivastigmine tartrate ee jirka waa mid gaaban oo wakhtiga ficilku waa dheer yahay.Si ka duwan tacrine, alaabtani waxay leedahay saameyn adag oo ka hortag ah oo ku saabsan enzyme G1 ee hippocampus iyo kortex.Waxa kiliinikada loo isticmaalaa in lagu daweeyo waallida fudud ama dhexdhexaadka ah ee Alzheimers, kaas oo looga shakisan yahay cudurka Alzheimers ama cudurka Alzheimers.
1. Sida acetylcholinesterase inhibitor, rivastigmine bicartrate waxay wanaajin kartaa saameynta nasashada muruqa succinylcholine.Sidaa darteed, waa inay jirtaa wakhti ku habboon oo isdhexgal ah si loo joojiyo qaadashada alaabtan ka hor suuxinta.Alaabtan waa in lagu daraa daawooyinka kale ee cholinergic ama anticholinergic, waana in taxaddar la sameeyaa (eeg [Isdhexgalka daroogada]).
2. Sababtoo ah saameyntooda farmasiga, cholinesterase inhibitors waxaa laga yaabaa inay saameyn ku yeeshaan dareenka dareenka ee garaaca wadnaha.Sida dawooyinka kale ee cholinergic, taxaddar waa in la sameeyaa marka la siinayo bukaanada qaba xanuunka sinus syndrome ama wadno qabadyada kale (eeg falcelinta xun).
3. Kacsiga neerfaha ee Cholinergic waxay keeni kartaa korodhka dheecaanka aashitada gastric.In kasta oo aan la helin caddayn muujinaysa inay si weyn uga sii dartay calaamadaha u dhigma inta lagu jiro muddada tijaabada kiliinikada, bukaannada leh khatarta sare ee boogaha gastric, sida kuwa leh taariikhda cudurka boogaha ama kuwa qaata daaweyn isku dhafan oo leh dawooyinka anti-inflammatory non-steroidal, waa in si taxadar leh loo isticmaalo.
4. Sida kuwa kale ee cholinesterase inhibitors, bukaanada qaba taariikhda neefta ama cudurada sambabada xannibaadda waa in si taxadar leh loo isticmaalo.