Pramipexole Dihydrochloride Monohydrate CAS 191217-81-9 Su'ega 98.0~102.0%
O le Ruifu Chemical o le taʻutaʻua taʻutaʻua o le Pramipexole Dihydrochloride Monohydrate (CAS: 191217-81-9) ma le maualuga.Ruifu Chemical e mafai ona tuʻuina atu i le lalolagi atoa, tau faʻatauvaʻa, auaunaga sili ona lelei, laʻititi ma tele tele o loʻo avanoa.Fa'atau Pramipexole Dihydrochloride Monohydrate,Please contact: alvin@ruifuchem.com
| Igoa Vailaau | Pramipexole Dihydrochloride Monohydrate |
| Synonyms | Pramipexole DiHCL Monohydrate;Pramipexole 2HCl Monohydrate;(S)-2-Amino-4,5,6,7-Tetrahydro-6-(Propylamino)benzothiazole Dihydrochloride Monohydrate |
| Tulaga Fa'asoa | I Fa'atauga, Gaosiga Fa'apisinisi |
| Numera CAS | 191217-81-9 |
| Fa'atatau CAS | 104632-25-9 & 104632-26-0 |
| Fuafua mole | C10H17N3S·2HCl·H2O |
| Molecular Weight | 302.26 g/mol |
| Lisi Lisi | 290℃(tes.) |
| Ta'amilosaga Fa'apitoa [a]20/D | -65.0° i le -71.0° (C=1 i le MeOH)(calcd.on anh.substance) |
| Suavai Solubility | Solu i le Vai |
| Solubility | Solu i le Methanol.Laititi Ethanol.E le mafai ona solu i le Dichloromethane |
| COA & MSDS | Avanoa |
| Amataga | Shanghai, Saina |
| Fa'ailoga | Ruifu Chemical |
| Aitema | Fa'amatalaga | I'uga |
| Fa'aaliga | Pa'epa'e i le Pa'epa'e Pa'epa'e | Pa'u Pa'epa'e |
| Su'ega (e le HPLC) | 98.0~102.0% | 99.34% |
| Vai saunia e Karl Fischer | 4.5~6.5% | E usitaia |
| Toega i luga o le mumu | ≤0.10% | <0.10% |
| Metala mamafa (Pb) | ≤10ppm | <10ppm |
| Pramipexole propionamidea | ≤0.15% | E usitaia |
| Pramipexole Related Compound A | ≤0.15% | E usitaia |
| N-Propylpramipexole | ≤0.15% | E usitaia |
| Pramipexole Dimer | ≤0.15% | E usitaia |
| So'o se isi mea leaga ta'ito'atasi e le'i fa'ailoaina | ≤0.10% | E usitaia |
| Enantiomeric Mama | ≤1.00% | E usitaia |
| Palladium | ≤5ppm | <5ppm |
| Alaleo Infrared | Ia ogatasi ma le Fauga | E usitaia |
| 1H NMR Alaleo | Ia ogatasi ma le Fauga | E usitaia |
| Fa'ai'uga | Ua uma ona fa'ata'ita'iina le oloa ma fa'amalieina fa'atonuga | |
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C10H17N3S·2HCl·H2O 302.26
(S)-2-Amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate [191217-81-9].
FAAMATALAGA
Pramipexole Dihydrochloride o loʻo iai le NLT 98.0% ma le NMT 102.0% o le C10H19Cl2N3S, faʻatatau i luga o le faʻavae anhydrous.
FAATINOGA
• A. Infrared Absorption <197A> po'o <197M>
Ole numera ole galu: <197A>, 3800 cm-1 i le 650 cm-1;<197M>, 4000 cm-1 i le 600 cm-1
• B. O le taimi fa'atumauina o le tumutumu tele i le fa'ata'ita'iga fofo e fetaui ma le pramipexole (S-enantiomer) i le fa'aogaina o le System i le su'ega mo Enantiomeric Purity.
• C. Su'ega Fa'ailoa-Aoao, Chloride <191>
Fa'ata'ita'iga: 1 mg/mL o le Pramipexole Dihydrochloride ile vai
Ta'iala e talia ai: Fa'amalieina mana'oga o le su'ega o le fa'ata'ita'iga o le fa'ameamea
SU'ESU'EGA
• Taualumaga
Fofo A: Fa'amuta le 9.1 g o le potassium dihydrogen phosphate ma le 5.0 g o le sodium 1-octanesulfonate monohydrate i le 1 L o le vai.Fetuuna'i ile phosphoric acid ile pH ole 3.0.
Fofo B: Acetonitrile ma Fofo A (1:1)
Diluent: Acetonitrile ma Fofo A (1: 4)
Vaega feavea'i: Va'ai le laulau fa'alili i lalo.
Taimi (min) Fofo A (%) Fofo B (%)
0 60 40
15 20 80
15.1 60 40
20 60 40
Fofo talafeagai o le faiga: 1.5 mg/mL o le USP Pramipexole Dihydrochloride RS ma le 0.8 mg/mL o le USP Pramipexole Related Compound A RS ile Diluent
Fofo masani: 1.5 mg/mL o le USP Pramipexole Dihydrochloride RS ile Diluent
Fa'ata'ita'iga fofo: 1.5 mg/mL o le Pramipexole Dihydrochloride i le Diluent
Faiga fa'akomepiuta
(Va'ai Chromatography <621>, Faiga Fa'atonu.)
Auala: LC
Su'esu'e: UV 264 nm
Koluma: 4.6-mm × 15-cm;5-µm fa'apipi'i L1
vevela o le koluma: 40 ± 5
Fuafuaga tafe: 1.5 mL/min
Tele tui: 5 µL
Faiga talafeagai
Fa'ata'ita'iga: Fa'ata'ita'iga talafeagai fa'aoga ma vaifofo masani [Fa'aaliga-O taimi fa'amautu mo le pramipexole feso'ota'i fa'atasi A ma le pramipexole e tusa ma le 0.7 ma le 1.0, fa'asologa.]
Mana'oga talafeagai
I'uga: NLT 6.0 i le va o le pramipexole feso'ota'i fa'atasi A ma le pramipexole, Fa'atonuga fa'aoga fofo.
Fa'ailoga fa'ailoga: NMT 2.0 mo le pramipexole, Fa'atonuga fa'aoga fofo
Feso'ota'iga tulaga masani: NMT 1.0%, Fofo masani
Iloiloga
Faʻataʻitaʻiga: Fofo masani ma Faʻataʻitaʻiga fofo
Fa'atatau le pasene ole C10H19Cl2N3S ile vaega ole Pramipexole Dihydrochloride na ave:
I'uga = (rU/rS) × (CS/CU) × (Mr1/Mr2) × 100
rU = tali maualuga mai le faʻataʻitaʻiga fofo
rS = tali pito i luga mai le fofo masani
CS = fa'atonuga o le USP Pramipexole Dihydrochloride RS i le fofo masani (mg/mL)
CU = fa'atonuga o le fa'ata'ita'iga fofo (mg/mL)
Mr1 = mamafa mole o le pramipexole dihydrochloride, 284.26
Mr2 = mamafa mole o le pramipexole dihydrochloride monohydrate, 302.26
Ta'iala talia: 98.0%–102.0% i luga ole fa'avae ole vai
LELEI
Fa'aleaga Fa'aletino
• Toega ile mumu <281>: NMT 0.10%
• Uamea Mamafa, Metotia I <231>
Fofo masani: Fofo Ta'ita'i Tulaga, 10 ppm
Fa'ata'ita'iga fofo: Lefulefu 2 g o le Pramipexole Dihydrochloride se'ia o'o ina maua se fa'amamago, carbonized mass.Fa'alili le toega, fa'aopopo le 2.0 mL o le nitric acid concentrated ma le 5 matau'a o le sulfuric acid fa'asa'o, ma fa'ataga ma le fa'aeteete e fa'atupu le asu.Fa'amumu ile 500-600 se'ia mu atoa le kaponi.Fa'alili le toega, fa'aopopo le 4 mL o le 6 M hydrochloric acid, ufiufi le fagu, ma fa'afefe i luga o se vai taele mo le 15 min.Fa'asao i le mago.Faaopopo le tasi mataua o le hydrochloric acid concentrated ma le 10 mL o le vai vevela, ma eli mo se isi 2 minute i luga o le vai taele.Fa'aopoopo le vaifofo o le ammonia 6 M i lalo i lalo seia o'o ina vaivai le alkaline o le vaifofo, ma fetuunai i le 1 M acetic acid i le pH o le 3.0-4.0.Fa'amama le vaifofo i totonu o se fagu volumetric 25-mL, ma fa'afefe i le vai i le 25 mL e ala i le fufuluina o le fagu ma le faamama.
Ta'iala talia: NMT 10 ppm
Oona Fa'aleaga
• Taualumaga
Fofo A, Fofo B, Diluent, Vaega feavea'i, ma le Chromatographic system: Fa'agasolo e pei ona fa'atonuina i le Su'ega.
Fofo fa'aoga talafeagai: 7.5 µg/mL o le USP Pramipexole Dihydrochloride RS ma le 3 µg/mL o le USP Pramipexole Related Compound A RS ile Diluent
Fofo masani: 1.5 µg/mL o le USP Pramipexole Dihydrochloride RS ile Diluent
Fa'ata'ita'iga fofo: 1.5 mg/mL o le Pramipexole Dihydrochloride i le Diluent
Faiga talafeagai
Fa'ata'ita'iga: Fa'atonuga fa'aoga vaifofo ma fofo Fa'atonu
Mana'oga talafeagai
I'uga: NLT 6.0 i le va o le pramipexole feso'ota'i fa'atasi A ma le pramipexole, Fa'atonuga fa'aoga fofo.
Fa'ailoga fa'ailoga: NMT 2.0 mo le pramipexole, Fa'atonuga fa'aoga fofo
Feso'ota'iga tulaga masani: NMT 5.0%, Fofo masani
Iloiloga
Faʻataʻitaʻiga: Fofo masani ma Faʻataʻitaʻiga fofo
Fa'atatau le pasene o so'o se mea e le mama i totonu o le vaega ole Pramipexole Dihydrochloride na ave:
I'uga = (rU/rS) × (CS/CU) × (Mr1/Mr2) × 100
rU = tali pito i luga ole eleelea ta'itasi mai le fofo Fa'ata'ita'i
rS = tali pito i luga ole pramipexole mai le vaifofo masani
CS = fa'atonuga o le USP Pramipexole Dihydrochloride RS i le fofo masani (mg/mL)
CU = fa'atonuga o le pramipexole dihydrochloride monohydrate i le fa'ata'ita'iga fofo (mg/mL)
Mr1 = mamafa mole o le pramipexole dihydrochloride, 284.26
Mr2 = mamafa mole o le pramipexole dihydrochloride monohydrate, 302.26
Tulaga taliaina
Fa'aleaga tagata ta'ito'atasi: Va'ai Fuafuaga Le mama 1.
Aofa'iga o mea leaga: NMT 0.5%
Fa'aleaga Laulau 1
Igoa Taimi Fa'atumauina Tulaga Fa'atonuga Talia, NMT (%)
Pramipexole propionamidea 0.5 0.15
Pramipexole feso'ota'iga fa'atasi Ab 0.7 0.15
Pramipexole 1.0 —
N-Propylpramipexolec 1.4 0.15
Pramipexole dimerd 1.7 0.15
So'o se isi mea leaga e le'i fa'ailoaina - 0.10
a (S)-N-(2-Amino-4,5,6,7-tetrahydrobenzothiazol-6-yl) propionamide.
b (S)-4,5,6,7-Tetrahydrobenzothiazole-2,6-diamine.
c (S)-2,6-Dipropylamino-4,5,6,7-tetrahydrobenzothiazole.
d N6,N6'-[2-Methylpentane-1,3-diyl]bis(4,5,6,7-tetrahydrobenzothiazole-2,6-diamine).Ole dimer ole pramipexole (se fa'afefiloi ole fa ole isomers).
SU'E FA'AMANATU
• Fuafuaga Suavai, Metotia I <921>: NLT 4.5% ma le NMT 6.5%
• Enantiomeric Mama
Vaega fe'avea'i: n-Hexane, ava malosi fa'amama, ma le diethylamine (850:150:1)
Fofo fa'asoaga talafeagai ile faiga: 1 mg/mL ta'itasi USP Pramipexole Dihydrochloride RS ma le USP Pramipexole Related Compound D RS ile 'ava malosi
Fofo fa'aoga talafeagai: 0.01 mg/mL ta'itasi USP Pramipexole Dihydrochloride RS ma le USP Pramipexole Related Compound D RS mai Fa'atonuga fa'asoa fa'asoa vaifofo ile vaega feavea'i.
Fofo fa'asoa masani: 2.0 mg/mL o le USP Pramipexole Related Compound D RS i le 'ava malosi
Fofo masani: 1.5 µg/mL o le USP Pramipexole Related Compound D RS i le vaega feavea'i
Fa'ata'ita'iga vaifofo: 0.3 mg/mL, saunia e ala i le fa'amavaeina o se aofa'iga talafeagai o le Pramipexole Dihydrochloride i le 25% o le fagu vai o le ava fa'amama ma fa'afefeteina i le vaega feavea'i i le voluma.
Faiga fa'akomepiuta
(Va'ai Chromatography 621, Faiga Fa'atonu.)
Auala: LC
Su'esu'e: UV 254 nm
Koluma: 4.6-mm × 25-cm;10-µm fa'apipi'i L51
Fuafuaga tafe: 1.5 mL/min
Fa'ata'ita'iga tele: 75 µL
Faiga talafeagai
Fa'ata'ita'iga: Fa'ata'ita'iga talafeagai fa'aoga [Fa'aaliga-O taimi fa'amautu mo le pramipexole feso'ota'i fa'atasi D (R-enantiomer) ma le pramipexole (S-enantiomer) e 0.5 ma le 1.0, fa'asologa.]
Mana'oga talafeagai
I'uga: NLT 5.0 i le va o le pramipexole e feso'ota'i fa'atasi D ma le pramipexole, Fa'atonu fa'aoga fofo.
Fa'ailoga fa'ailoga: NMT 2.4 mo pramipexole, Fa'atonuga fa'aoga fofo
Iloiloga
Faʻataʻitaʻiga: Fofo masani ma Faʻataʻitaʻiga fofo
Fa'atusatusa le pasene o le pramipexole related compound D i le vaega ole Pramipexole Dihydrochloride na ave:
I'uga = (rU/rS) × (CS/CU) × 100
rU = tali pito i luga ole pramipexole e feso'ota'i fa'atasi D mai le fa'ata'ita'iga fofo
rS = tali pito i luga ole pramipexole feso'ota'iga fa'atasi D mai le vaifofo masani
CS = fa'amaualuga o le fa'aogaina o le pramipexole D i le fofo masani (mg/mL)
CU = fa'atonuga o le fa'ata'ita'iga fofo (mg/mL)
Ta'iala e talia ai: NMT 1.0% ole vaega ole pramipexole D
• Tapulaa o Palladium
[Manatua-Faia lenei su'ega pe a fai o le palladium o se mea e le mama.]
Diluent: 0.1 M hydrochloric acid
Fofo masani: 40 µg/L o le palladium i le Diluent, mai fa'atau fa'atau fa'atauva'a vaifofo fa'ata'ita'i mo le fa'atomeki fa'atomu/fa'aulu fa'atasi plasma.[Manatua—Ia saunia fou lenei vaifofo pe a manaʻomia i le aso e faʻaaoga ai.]
Fa'ata'ita'iga vaifofo: I le 0.5 g o le Pramipexole Dihydrochloride i totonu o se fagu volumetric 50-mL fa'aopopo le 5.00 mL o le 1 M hydrochloric acid, ma fa'amavae ma fa'avevela.Fa'alili i le vevela potu, ma fa'afefe i le vai i le voluma.
Tulaga spectrometric
(Va'ai Spectrophotometry ma le Fa'asa'oina o Malamalama 851).
Ala: Atomic absorption spectrophotometry
Ole umi ole galu: Palladium emission laina ile 247.6 nm
Lamepa: Cathode omo
Punavai fa'atosina: ogaumu kalafi.[Manatua—Mulimuli i le faasologa o polokalame fautuaina a le gaosi oloa.]
Tele fa'ata'ita'iga: 20 µL
Avanoa: fa'afefeteina
Faiga talafeagai
Fa'ata'ita'iga: Fofo masani
Mana'oga talafeagai
Fa'asa'o: NLT 0.034
Iloiloga
Faʻataʻitaʻiga: Fofo masani ma Faʻataʻitaʻiga fofo
Fuafua le faʻaogaina o le palladium i le faʻataʻitaʻiga fofo e ala i le faʻaopoopoga masani.
Ta'iala talia: NMT 5 ppm
FAAOPOOPOGA
• Fa'auma ma Teuina: Fa'asao i totonu o pusa tapuni lelei, puipuia mai le susu ma le malamalama.
• USP Reference Standards 11
USP Pramipexole Dihydrochloride RS Kiliki e Va'ai le Fauga
USP Pramipexole Related Compound A RS
(S) -4,5,6,7-Tetrahydrobenzothiazole-2,6-diamine.
C7H11N3S 169.25
USP Pramipexole Related Compound D RS
(R)-2-Amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole.
C10H17N3S 211.33
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H
O lo'o fa'aaogaina le Pramipexole Dihydrochloride Monohydrate (CAS: 191217-81-9).
