Rivastigmine Tartrate CAS 129101-54-8 Assay 98.0 ~ 102.0
Shanghai Ruifu Chemical Co., Ltd bụ onye na-emepụta Rivastigmine Tartrate (CAS: 129101-54-8) nwere àgwà dị elu.Ruifu Chemical nwere ike ịnye nnyefe zuru ụwa ọnụ, ọnụahịa asọmpi, ọrụ magburu onwe ya, obere na nnukwu ọnụọgụ dị.Zụrụ Rivastigmine Tartrate,Please contact: alvin@ruifuchem.com
| Aha Chemical | Rivastigmine Tartrate |
| Ụdị okwu | 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 |
| Ọnọdụ Ahịa | Na ngwaahịa, Mmepụta Azụmahịa |
| Nọmba CAS | 129101-54-8 |
| CAS metụtara | 123441-03-2 |
| Usoro ihe omimi | C14H22N2O2·C4H6O6 |
| Ibu molekụla | 400.43 g/mol |
| Ebe Na-agbaze | 124.0 ruo 128.0 ℃ |
| Ntụgharị a kapịrị ọnụ [a]20/D | +4.0° ruo +7.0° (C=5, methanol) |
| Solubility | Soluble na methanol |
| COA & MSDS | Dị |
| Mmalite | Shanghai, China |
| Ụdị | Ruifu Chemical |
| Ihe | Ụkpụrụ nyocha | Nsonaazụ |
| Ọdịdị | Ntụ ntụ kristal na-acha ọcha ruo na-agbanyụọ | Na-akwado |
| Nyocha | 98.0 ~ 102.0% (na Anhydrous ndabere) | 99.8% |
| Mmiri nke Karl Fischer | ≤0.50% | 0.15% |
| Ihe fọdụrụ na mgbanye | ≤0.10% | 0.07% |
| Ọla dị arọ (Pb) | ≤20ppm | <10ppm |
| Phenol adịghị ọcha | ≤0.30% | <0.30% |
| DPTTA | ≤0.15% | <0.15% |
| Ma ọ bụ adịghị ọcha | ≤0.15% | <0.15% |
| Carbamate adịghị ọcha | ≤0.15% | <0.15% |
| Ether adịghị ọcha | ≤0.15% | <0.15% |
| Ọdịghị ọcha ọ bụla ọzọ | ≤0.10% | <0.10% |
| Mgbakọta adịghị ọcha | ≤0.50% | <0.50% |
| R-Enantiomer | ≤0.30% | <0.30% |
| Spectrum infrared | Nkwekọ na Structure | Na-akwado |
| 1H NMR Spectrum | Nkwekọ na Structure | Na-akwado |
| Mmechi | A nwalela ngwaahịa a wee kwado ụkpụrụ USP35 | |
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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].
Nkọwa
Rivastigmine Tartrate nwere NLT 98.0% na NMT 102.0% nke ego akpọrọ C14H22N2O2·C4H6O6, gbakọọ na usoro anhydrous.
Nchọpụta
• A. Infrared Absorption <197K>
• B. Oge njide nke isi ọnụ ọgụgụ kachasị elu nke ihe ngwọta Sample kwekọrọ na nke ngwọta kwesịrị ekwesị nke Sistemu, dị ka enwetara na ule maka adịghị ọcha nke Organic, Usoro 2: Enantiomeric Purity.
ASSAY
• Usoro
Nchekwa: 8.6 mg/mL nke monobasic ammonium phosphate.Gbanwee na ngwọta amonia na pH nke 7.0.
Usoro mkpanaka: methanol, acetonitrile, na ihe nchekwa (15:15:70)
Ngwọta ndabara sistemu: 0.05 mg/mL nke ọ bụla nke USP Rivastigmine metụtara Compound A RS na USP Rivastigmine metụtara Compound B RS na usoro mkpanaka.
Ngwọta ọkọlọtọ: 0.2 mg/mL nke USP Rivastigmine Tartrate RS na usoro mkpanaka
Ngwọta nlele: 0.2 mg/mL nke Rivastigmine Tartrate na usoro mkpanaka
Sistemụ chromatographic
(Lee Chromatography <621>, Kwesịrị ekwesị Sistemu.)
Ụdị: LC
Ihe nchọpụta: UV 215 nm
Ogidi: 4.6-mm × 25-cm;5-µm nkwakọ ngwaahịa L7
Ọnụego mmiri: 1.2 ml / min
Nha igba ogwu: 20µL
[Rịba ama-Enwere ike gbanwee ọnụego nrịba ahụ ka ọ bụrụ 1.5 mL / min, ọ bụrụ na ọ dị mkpa, iji nweta oge njigide nke rivastigmine na ihe dịka 10 min.]
Sistemu kwesịrị ekwesị
Nlereanya: Ngwọta dabara adaba sistemu na ngwọta ọkọlọtọ
Kwesịrị ekwesị chọrọ
Mkpebi: NLT 1.5 n'etiti rivastigmine metụtara compound A na rivastigmine metụtara compound B, usoro dabara adaba
Nrụ ọrụ kọlụm: NLT 5000 theoretical plates, Standard Solution
Isi ihe ọdụdụ: NMT 3.0, Ọkọlọtọ ngwọta
Ọkọlọtọ emetụtara: NMT 2.0%, Ọkọlọtọ ngwọta
Nyocha
Ihe atụ: Ngwọta ọkọlọtọ na ngwọta nlele
Gbakọọ pasent C14H22N2O2·C4H6O6 n'akụkụ Rivastigmine Tartrate were:
Nsonaazụ = (rU/rS) × (CS/CU) × 100
rU = nzaghachi kacha elu sitere na ngwọta Sample
rS = nzaghachi kacha elu sitere na ngwọta Standard
CS = itinye uche nke ngwọta ọkọlọtọ (mg/mL)
CU = itinye uche nke ngwọta nlele (mg/mL)
Usoro nnabata: 98.0% -102.0% na ndabere anhydrous
IHE adịghị ọcha
Ihe adịghị ọcha
• Ihe fọdụrụ na mgbanye <281>: NMT 0.1%
• Ọla dị arọ, Usoro II <231>: NMT 20 ppm
Ihe adịghị ọcha
• Usoro nke 1
Usoro mkpanaaka na ngwọta dabara na sistemu: Gaba n'ihu dịka enyere ya na nyocha.
Ngwọta ọkọlọtọ: 1.0 μg/mL nke USP Rivastigmine Tartrate RS na usoro mkpanaaka
Ngwọta nlele: 1.0 mg/mL nke Rivastigmine Tartrate na usoro mkpanaka
Sistemu Chromatographic: Gaba n'ihu dịka enyere ya na nyocha.
(Lee Chromatography <621>, Kwesịrị ekwesị Sistemu.)
Sistemu kwesịrị ekwesị
Nlereanya: Ngwọta dabara adaba sistemu na ngwọta ọkọlọtọ
Kwesịrị ekwesị chọrọ
Mkpebi: NLT 1.5 n'etiti rivastigmine metụtara compound A na rivastigmine metụtara compound B, usoro dabara adaba
Ọkọlọtọ emetụtara: NMT 10%, Ọkọlọtọ ngwọta
Nyocha [Rịba ama-Oge a na-agba ọsọ bụ oge 8 jigide nke ọnụ ọgụgụ rivastigmine.]
Ihe atụ: Ngwọta ọkọlọtọ na ngwọta nlele
Gbakọọ pasent nke adịghị ọcha onye ọ bụla na akụkụ Rivastigmine Tartrate ewepụtara:
Nsonaazụ = (rU/rS) × (CS/CU) × (1/F) × 100
rU = nzaghachi kacha elu maka adịghị ọcha ọ bụla site na ngwọta Sample
rS = nzaghachi kacha elu sitere na ngwọta Standard
CS = itinye uche nke USP Rivastigmine Tartrate RS na ngwọta ọkọlọtọ (mg/mL)
CU = itinye uche nke Rivastigmine Tartrate na ngwọta nlele (mg/mL)
F = ihe nzaghachi nke ikwu (lee Tebụl adịghị ọcha 1)
Usoro nnabata
Ihe adịghị ọcha n'otu n'otu: Lee Tebụl adịghị ọcha 1.
Mkpokọta adịghị ọcha: NMT 0.5%
Tebụl adịghị ọcha 1
| Aha | Oge Njide Oyiyi | Ihe Nzaghachi Ndị ikwu | Usoro nnabata NMT % |
| Tartrate | 0.18 | - | Na-eleghara anya |
| phenol adịghị ọcha | 0.28 | 1.6 | 0.3 |
| DPTTAB | 0.46 | 0.83 | 0.15 |
| Ma ọ bụ adịghị ọcha | 0.57 | 1.2 | 0.15 |
| Rivastigmine | 1.0 | 1.0 | - |
| Carbamate adịghị ọcha | 4.1 | 1.3 | 0.15 |
| Ether adịghị ọcha | 6.5 | 1.4 | 0.15 |
| Ọdịghị ọcha ọ bụla ọzọ | - | 1.0 | 0.1 |
a (S) -3-[1- (Dimethylamino) ethyl] phenol.
b (+) - Di- (p-toluoyl) -d-tartaric acid (ihe metụtara rivastigmine A).
c (S) -3- [1- (Dimethylamino) ethyl] phenyl dimethylcarbamate (ihe metụtara rivastigmine B).
d 3-Nitrophenyl ethyl (methyl) carbamate.
e (S) -N, N-Dimethyl-1-[3- (4-nitrophenoxy) phenyl] etanamine.
• Usoro 2: Ịdị ọcha Enantiomeric
Nchekwa: Nyefee 1.78 g nke dibasic sodium phosphate dihydrate na 1.38 g nke monobasic sodium phosphate n'ime iko volumetric 1000-mL.Gbanyụọ ma gbanye mmiri ka ọ bụrụ olu.Gbanwee ya na phosphoric acid ka ọ bụrụ pH nke 6.0.
Usoro mkpanaaka: Nyefee 20 ml nke acetonitrile na 205 µL nke N, N-dimethylotylamine na flask volumetric 1000-mL, wee tụgharịa na Buffer gaa na olu.
Ngwọta ọkọlọtọ: 0.1 µg/mL nke USP Rivastigmine Tartrate R-Isomer RS na usoro mkpanaka.
Ngwọta mmetụta uche: 0.05 µg/mL nke USP Rivastigmine Tartrate R-Isomer RS na usoro mkpanaaka, ngwọta ọkọlọtọ.
Ngwọta nke dabara na sistemụ: 100 µg/mL nke USP Rivastigmine Tartrate RS na 0.1 μg/mL nke USP Rivastigmine Tartrate R-Isomer RS na usoro mkpanaka.
Ngwọta nlele: 100 µg/mL nke Rivastigmine Tartrate na usoro mkpanaka
Sistemụ chromatographic
(Lee Chromatography <621>, Kwesịrị ekwesị Sistemu.)
Ụdị: LC
Ihe nchọpụta: UV 200 nm
Ogidi: 4.0-mm × 10-cm;mbukota L41
Ọnụego mmiri: 0.5 ml / min
Nha igba ogwu: 20µL
Sistemu kwesịrị ekwesị
Nlereanya: Ngwọta ọkọlọtọ, ngwọta mmetụta uche, yana ngwọta dabara adaba sistemụ
Kwesịrị ekwesị chọrọ
Mkpebi: NLT 0.8 n'etiti elu enantiomer, usoro dabara adaba
[Rịba ama- Usoro elution bụ R-enantiomer, na-esote ọnụ ọgụgụ rivastigmine, nke bụ S-enantiomer.]
Oke mgbaàmà na mkpọtụ: NLT 10, ngwọta mmetụta uche
Ọkọlọtọ emetụtara: NMT 10%, Ọkọlọtọ ngwọta
Nyocha
Ihe atụ: Ngwọta ọkọlọtọ na ngwọta nlele
Gbakọọ pasent R-enantiomer na akụkụ Rivastigmine Tartrate ewepụtara:
Nsonaazụ = (rU/rS) × (CS/CU) × 100
rU = nzaghachi kacha elu nke R-enantiomer sitere na ngwọta Sample
rS = nzaghachi kacha elu nke R-enantiomer sitere na ngwọta Standard
CS = ntinye nke R-enantiomer na ngwọta ọkọlọtọ (µg/mL)
CU = itinye uche nke Rivastigmine Tartrate na ngwọta nlele (µg/mL)
Usoro nnabata: NMT 0.3% nke R-enantiomer
Nnwale akọwapụtara
• Mkpebi mmiri, Usoro IA <921>: NMT 0.5%
NKWUO GBASARA YA
• Nkwakọ ngwaahịa na Nchekwa: Chekwaa n'ime akpa siri ike, ma chekwaa na ụlọ okpomọkụ.
• Ụkpụrụ ntụaka USP <11>
USP Rivastigmine Tartrate RS
Ngwakọta jikọrọ USP Rivastigmine A RS
Di-p-toluoyl-d-(+) -tartaric acid monohydrate.
C20H20O9 404.37
Ihe jikọrọ USP Rivastigmine 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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Otu ngwugwu III
Rivastigmine Tartrate (CAS: 129101-54-8) bụ tartrate nke rivastigmine, ọgwụ maka ọgwụgwọ ọrịa Alzheimer.Rivastigmine bụ ihe ewepụtara physostigmine, nke Novartis, Switzerland mebere nke ọma na nke mbụ ya.Aha ahia ahụ bụ exelon, molecule ahụ nwekwara usoro benzyl carbamate, ọ bụ ụbụrụ ụbụrụ nke na-ahọrọ cholinesterase inhibitor, nke nwere ike igbochi acetylcholinesterase na butyrylcholinesterase n'otu oge, ma kwalite nchịkwa akwara cholinergic site n'igbu oge mmebi nke acetylcholine wepụtara site na cholinergic. neurons.Ọ nwere ike imeziwanye arụmọrụ nke cognition nke cholinergic na-emezi, si otú a na-emeziwanye mmetụta uche nke ndị ọrịa nwere ọrịa Alzheimer.Ike ijikọ protein plasma nke rivastigmine adịghị ike, ọ dị mfe ịgafe ihe mgbochi ụbụrụ ọbara, ma nwee oke nhọrọ ụbụrụ.Ọ bụghị naanị na ọ nwere ike họrọ ime ihe na mpaghara ndị kachasị emerụ ahụ nke cortex ụbụrụ na hippocampus, kamakwa ọ na-amachi igbochi ụdị isi nke AChE n'ụbụrụ, nke nwere ike belata nsonaazụ cholinergic mpaghara ebe ọ na-emepụta mmetụta ọgwụgwọ.Ọkara ndụ nke rivastigmine tartrate n'ime ahụ dị mkpụmkpụ na oge ime ihe dị ogologo.N'adịghị ka tacrine, ngwaahịa a nwere mmetụta mgbochi siri ike na G1 enzyme na hippocampus na cortex.A na-eji ya n'ụlọ ọgwụ na-agwọ ọrịa nrịanrịa Alzheimer dị nro ma dị obere, nke a na-enyo enyo na ọ bụ ọrịa Alzheimer ma ọ bụ ọrịa Alzheimer.
1. Dị ka acetylcholinesterase inhibitor, rivastigmine bicartrate nwere ike melite mmetụta nke succinylcholine muscle relaxant.Ya mere, ekwesịrị inwe oge nkwụsịtụ kwesịrị ekwesị iji kwụsị ịre ngwaahịa a tupu ịwa ahụ.Ekwesịrị ijikọ ngwaahịa a na ọgwụ ndị ọzọ cholinergic ma ọ bụ anticholinergic, ma ekwesịrị ịkpachara anya (lee [Mmekọrịta ọgwụ]).
2. N'ihi mmetụta ha na-emepụta ọgwụ, ndị na-emechi cholinesterase nwere ike inwe mmetụta nhụjuanya akwara vagus na ọnụọgụ obi.Dị ka ọ dị na ọgwụ cholinergic ndị ọzọ, a ghaghị ịkpachara anya mgbe a na-enye ndị ọrịa na-arịa ọrịa sinus syndrome ma ọ bụ ngọngọ obi ọzọ (lee Mmeghachi omume ọjọọ).
3. Mmasị akwara cholinergic nwere ike ime ka ụbara secretion acid gastric.Ọ bụ ezie na ọ nweghị ihe akaebe na-egosi mbelata dị ịrịba ama nke mgbaàmà kwekọrọ na ya n'oge oge ikpe ụlọ ọgwụ, ndị ọrịa nwere nnukwu ihe ize ndụ nke ọnya afọ, dị ka ndị nwere akụkọ ihe mere eme nke ọrịa ọnya ma ọ bụ ndị na-anata ọgwụgwọ concomitant na ọgwụ ndị na-abụghị steroidal anti-inflammatory, kwesịrị iji nlezianya mee ihe.
4. Dị ka ndị ọzọ cholinesterase inhibitors, ndị ọrịa nwere akụkọ ihe mere eme nke ụkwara ume ọkụ ma ọ bụ ndị ọzọ na-egbochi akpa ume kwesịrị iji nlezianya mee ihe.
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