Pramipexole Dihydrochloride Monohydrate CAS 191217-81-9 Assay 98.0 ~ 102.0%
Kemikali Ruifu jẹ olupilẹṣẹ oludari ti Pramipexole Dihydrochloride Monohydrate (CAS: 191217-81-9) pẹlu didara to gaju.Kemikali Ruifu le pese ifijiṣẹ agbaye, idiyele ifigagbaga, iṣẹ ti o dara julọ, kekere ati awọn iwọn olopobobo ti o wa.Ra Pramipexole Dihydrochloride Monohydrate,Please contact: alvin@ruifuchem.com
| Orukọ Kemikali | Pramipexole Dihydrochloride Monohydrate |
| Awọn itumọ ọrọ sisọ | Pramipexole DiHCL Monohydrate;Pramipexole 2HCl Monohydrate;(S) -2-Amino-4,5,6,7-Tetrahydro-6- (Propylamino) benzothiazole Dihydrochloride Monohydrate |
| Iṣura Ipo | Ni Iṣura, Iṣowo Iṣowo |
| Nọmba CAS | Ọdun 191217-81-9 |
| CAS ti o ni ibatan | 104632-25-9 & 104632-26-0 |
| Fọọmu Molecular | C10H17N3S · 2HCl · H2O |
| Òṣuwọn Molikula | 302,26 g / mol |
| Ojuami Iyo | 290 ℃ (oṣu kejila) |
| Yiyi pato [a] 20/D | -65.0° si -71.0° (C=1 ninu MeOH)(calcd.on anh.nkan) |
| Omi Solubility | Tiotuka ninu Omi |
| Solubility | Tiotuka ni kẹmika.Ethanol Pupọ pupọ.Ailopin ninu Dichloromethane |
| COA & MSDS | Wa |
| Ipilẹṣẹ | Shanghai, China |
| Brand | Ruifu Kemikali |
| Awọn nkan | Awọn pato | Esi |
| Ifarahan | Funfun to Pa-White Powder | Funfun Powder |
| Ayẹwo (nipasẹ HPLC) | 98.0 ~ 102.0% | 99.34% |
| Omi nipa Karl Fischer | 4.5 ~ 6.5% | Ibamu |
| Aloku lori Iginisonu | ≤0.10% | <0.10% |
| Awọn Irin Eru (Pb) | ≤10ppm | <10ppm |
| Pramipexole Propionamidea | ≤0.15% | Ibamu |
| Agbo ti o jọmọ Pramipexole A | ≤0.15% | Ibamu |
| N-Propylpramipexole | ≤0.15% | Ibamu |
| Pramipexole Dimer | ≤0.15% | Ibamu |
| Eyikeyi Aimọ Olukuluku Ẹnikan ti a ko mọ | ≤0.10% | Ibamu |
| Enantiomeric ti nw | ≤1.00% | Ibamu |
| Palladium | ≤5ppm | <5ppm |
| Infurarẹẹdi julọ.Oniranran | Ni ibamu pẹlu Eto | Ibamu |
| 1H NMR julọ.Oniranran | Ni ibamu pẹlu Eto | Ibamu |
| Ipari | Ọja naa ti ni idanwo ati ni ibamu pẹlu awọn pato ti a fun | |
Apo:Igo Fluorinated, apo apamọwọ Aluminiomu, 25kg / Paali Drum, tabi gẹgẹbi ibeere alabara.
Ipò Ìpamọ́:Jeki apo eiyan naa ni wiwọ ni pipade ati tọju ni itura, gbẹ (2 ~ 8℃) ati ile-itaja ti o ni afẹfẹ daradara kuro ninu awọn nkan ti ko ni ibamu.Dabobo lati ina ati ọrinrin.
Gbigbe:Firanṣẹ si agbaye nipasẹ afẹfẹ, nipasẹ FedEx / DHL Express.Pese ifijiṣẹ yarayara ati igbẹkẹle.
C10H17N3S · 2HCl · H2O 302.26
(S) -2-Amino-4,5,6,7-tetrahydro-6- (propylamino) benzothiazole dihydrochloride monohydrate [191217-81-9].
ITUMO
Pramipexole Dihydrochloride ni NLT 98.0% ati NMT 102.0% ti C10H19Cl2N3S, iṣiro lori ipilẹ anhydrous.
Ìdámọ̀
• A. Gbigba infurarẹẹdi <197A> tabi <197M>
Iwọn nọmba igbi: <197A>, 3800 cm-1 si 650 cm-1;<197M>, 4000 cm-1 si 600 cm-1
• B. Akoko idaduro ti tente oke pataki ni ojutu Ayẹwo ni ibamu si ti pramipexole (S-enantiomer) ni ojutu ibamu System ni idanwo fun Enantiomeric Purity.
• C. Idanimọ-Gbogbogbo, Chloride <191>
Ayẹwo: 1 mg/mL ti Pramipexole Dihydrochloride ninu omi
Awọn ibeere gbigba: Pade awọn ibeere ti idanwo iyọkuro fadaka
ASAY
• Ilana
Solusan A: Tu 9.1 g ti potasiomu dihydrogen fosifeti ati 5.0 g ti iṣuu soda 1-octanesulfonate monohydrate ni 1 L ti omi.Ṣatunṣe pẹlu phosphoric acid si pH ti 3.0.
Solusan B: Acetonitrile ati Solusan A (1:1)
Diluent: Acetonitrile ati Solusan A (1:4)
Alakoso alagbeka: Wo tabili gradient ni isalẹ.
Akoko (min) Solusan A (%) Solusan B (%)
060 40
15 20 80
15.1 60 40
20 60 40
Ojutu ìbójúmu eto: 1.5 mg/mL ti USP Pramipexole Dihydrochloride RS ati 0.8 mg/mL ti USP Pramipexole Jẹmọ Compound A RS ni Diluent
Ojutu boṣewa: 1.5 mg/mL ti USP Pramipexole Dihydrochloride RS ni Diluent
Ojutu ayẹwo: 1.5 mg/mL ti Pramipexole Dihydrochloride ni Diluent
Eto Chromatographic
(Wo Chromatography <621>, Ibamu Eto.)
Ipo: LC
Oluwadi: UV 264 nm
Ọwọn: 4.6-mm × 15-cm;5-µm iṣakojọpọ L1
Iwọn otutu: 40 ± 5
Oṣuwọn sisan: 1.5 milimita / min
Iwọn abẹrẹ: 5µL
Ibamu eto
Awọn ayẹwo: Ojutu ibaamu eto ati ojutu Standard [Akiyesi-Awọn akoko idaduro ibatan fun idapọ ti o ni ibatan pramipexole A ati pramipexole jẹ nipa 0.7 ati 1.0, lẹsẹsẹ.]
Awọn ibeere ibamu
Ipinnu: NLT 6.0 laarin awọn nkan ti o ni ibatan pramipexole A ati pramipexole, ojutu ibamu eto
Idiwọn tailing: NMT 2.0 fun pramipexole, ojutu ibamu eto
Ojulumo boṣewa iyapa: NMT 1.0%, Standard ojutu
Onínọmbà
Awọn apẹẹrẹ: Ojutu boṣewa ati ojutu Ayẹwo
Ṣe iṣiro ipin ogorun C10H19Cl2N3S ni apakan ti Pramipexole Dihydrochloride ti o mu:
Esi = (rU/rS) × (CS/CU) × (Mr1/Mr2) × 100
rU = idahun ti o ga julọ lati inu ojutu Ayẹwo
rS = idahun ti o ga julọ lati ojutu Standard
CS = ifọkansi ti USP Pramipexole Dihydrochloride RS ninu ojutu Standard (mg/mL)
CU = ifọkansi ti ojutu Ayẹwo (mg/mL)
Mr1 = iwuwo molikula ti pramipexole dihydrochloride, 284.26
Mr2 = iwuwo molikula ti pramipexole dihydrochloride monohydrate, 302.26
Awọn ibeere gbigba: 98.0% -102.0% lori ipilẹ anhydrous
ALÁÌṢẸ́
Awọn Egbin Aiṣedeede
Aloku lori Iginisonu <281>: NMT 0.10%
• Awọn irin Heavy, Ọna I <231>
Standard ojutu: Standard Lead Solusan, 10 ppm
Ojutu Apeere: Ash 2 g ti Pramipexole Dihydrochloride titi di igba ti o fẹrẹ gbẹ, iwọn carbonized yoo gba.Tutu iyokù naa, ṣafikun 2.0 milimita ti nitric acid ti o ni idojukọ ati 5 silė ti sulfuric acid ogidi, ati farabalẹ gba awọn eefin naa lati dagbasoke.Ignite ni 500-600 titi ti erogba yoo fi jona patapata.Tutu iyoku naa, ṣafikun 4 milimita ti 6 M hydrochloric acid, bo crucible, ki o si dalẹ lori iwẹ omi farabale fun iṣẹju 15.Evaporate si gbigbẹ.Fi ọkan silẹ ti ogidi hydrochloric acid ati 10 milimita ti omi gbigbona, ki o si dalẹ fun iṣẹju 2 siwaju sii lori iwẹ omi farabale.Fi 6 M amonia ojutu silẹ titi ti ojutu naa yoo jẹ ipilẹ ailera, ki o ṣatunṣe pẹlu 1 M acetic acid si pH ti 3.0-4.0.Ṣe àlẹmọ ojutu naa sinu ọpọn iwọn didun 25-mL, ki o si fomi pẹlu omi si 25 milimita nipa fifọ erupẹ ati àlẹmọ.
Awọn ilana gbigba: NMT 10 ppm
Organic impurities
• Ilana
Solusan A, Solusan B, Diluent, Alakoso Alagbeka, ati eto Chromatographic: Tẹsiwaju bi a ti ṣe itọsọna ninu Ayẹwo.
Ojutu ìbójúmu eto: 7.5 µg/mL ti USP Pramipexole Dihydrochloride RS ati 3 µg/mL ti USP Pramipexole Jẹmọ Compound A RS ni Diluent
Ojutu boṣewa: 1.5 µg/ml ti USP Pramipexole Dihydrochloride RS ni Diluent
Ojutu ayẹwo: 1.5 mg/mL ti Pramipexole Dihydrochloride ni Diluent
Ibamu eto
Awọn apẹẹrẹ: Ojutu ibamu eto ati ojutu Standard
Awọn ibeere ibamu
Ipinnu: NLT 6.0 laarin awọn nkan ti o ni ibatan pramipexole A ati pramipexole, ojutu ibamu eto
Idiwọn tailing: NMT 2.0 fun pramipexole, ojutu ibamu eto
Ojulumo boṣewa iyapa: NMT 5.0%, Standard ojutu
Onínọmbà
Awọn apẹẹrẹ: Ojutu boṣewa ati ojutu Ayẹwo
Ṣe iṣiro ipin ogorun aimọ kọọkan kọọkan ni apakan ti Pramipexole Dihydrochloride ti o mu:
Esi = (rU/rS) × (CS/CU) × (Mr1/Mr2) × 100
rU = esi ti o ga julọ ti aimọ kọọkan lati inu ojutu Ayẹwo
rS = idahun ti o ga julọ ti pramipexole lati ojutu Standard
CS = ifọkansi ti USP Pramipexole Dihydrochloride RS ninu ojutu Standard (mg/mL)
CU = ifọkansi ti pramipexole dihydrochloride monohydrate ninu ojutu Ayẹwo (mg/mL)
Mr1 = iwuwo molikula ti pramipexole dihydrochloride, 284.26
Mr2 = iwuwo molikula ti pramipexole dihydrochloride monohydrate, 302.26
Awọn ilana gbigba
Awọn aimọ ẹnikọọkan: Wo Tabili Aimọ 1.
Lapapọ awọn aimọ: NMT 0.5%
Tabili àìmọ́ 1
Orukọ Awọn Apejuwe Gbigba Akoko Idaduro ibatan, NMT (%)
Pramipexole propionamidea 0.5 0.15
Pramipexole parapo Ab 0.7 0.15
Pramipexole 1.0 —
N-Propylpramipexolec 1.4 0.15
Pramipexole dimerd 1.7 0.15
Eyikeyi aimọ ẹni kọọkan aimọ - 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).Eyi jẹ dimer ti pramipexole (adapọ awọn isomers mẹrin ti o ṣeeṣe).
Awọn idanwo pataki
• Ipinnu Omi, Ọna I <921>: NLT 4.5% ati NMT 6.5%
• Enantiomeric ti nw
Ipele alagbeeka: n-Hexane, ọti ti a gbẹ, ati diethylamine (850:150:1)
Ojutu ọjà ìbójúmu ìbójúmu eto: 1 mg/mL kọọkan ti USP Pramipexole Dihydrochloride RS ati USP Pramipexole Jẹmọ Compound D RS ni oti gbígbẹ
Ojutu ibaamu eto: 0.01 miligiramu/mL kọọkan ti USP Pramipexole Dihydrochloride RS ati USP Pramipexole Compound ti o jọmọ D RS lati ojutu ibamu ibamu eto ni ipele Alagbeka
Ojutu ọja iṣura boṣewa: 2.0 mg/mL ti USP Pramipexole Compound Jẹmọ D RS ni oti gbígbẹ
Ojutu boṣewa: 1.5 µg/ml ti USP Pramipexole Compound Jẹmọ D RS ni ipele Alagbeka
Ojutu Apeere: 0.3 mg/mL, ti a pese sile nipasẹ itu opoiye iwuwo ti o yẹ ti Pramipexole Dihydrochloride ni 25% ti iwọn igo kan ti ọti ti o gbẹ ati diluting pẹlu apakan Alagbeka si iwọn didun
Eto Chromatographic
(Wo Chromatography 621, Ibamu Eto.)
Ipo: LC
Oluwadi: UV 254 nm
Ọwọn: 4.6-mm × 25-cm;10-µm iṣakojọpọ L51
Oṣuwọn sisan: 1.5 milimita / min
Iwọn apẹẹrẹ: 75 µL
Ibamu eto
Awọn ayẹwo: Ojutu ibaamu eto [Akiyesi-Awọn akoko idaduro ojulumo fun pramipexole ti o ni ibatan yellow D (R-enantiomer) ati pramipexole (S-enantiomer) jẹ 0.5 ati 1.0, lẹsẹsẹ.]
Awọn ibeere ibamu
Ipinnu: NLT 5.0 laarin awọn nkan ti o ni ibatan pramipexole D ati pramipexole, ojutu ibamu eto
Idiwọn tailing: NMT 2.4 fun pramipexole, ojutu ibamu eto
Onínọmbà
Awọn apẹẹrẹ: Ojutu boṣewa ati ojutu Ayẹwo
Ṣe iṣiro ipin idawọle pramipexole ti o ni ibatan D ni apakan ti Pramipexole Dihydrochloride ti o mu:
Esi = (rU/rS) × (CS/CU) × 100
rU = esi to ga ju ti pramipexole ti o ni ibatan yellow D lati inu ojutu Ayẹwo
rS = esi ti o ga julọ ti pipọ ti o ni ibatan pramipexole lati inu ojutu Standard
CS = ifọkansi ti nkan ti o ni ibatan pramipexole D ninu ojutu Standard (mg/mL)
CU = ifọkansi ti ojutu Ayẹwo (mg/mL)
Awọn ibeere gbigba: NMT 1.0% ti idapọ ti o ni ibatan pramipexole D
• Ifilelẹ ti Palladium
[Akiyesi-Ṣe idanwo yii ti palladium jẹ aimọ eleto ti a mọ.]
Diluent: 0.1 M hydrochloric acid
Ojutu boṣewa: 40 µg/L ti palladium ni Diluent, lati inu ojuutu boṣewa palladium ti o wa ni iṣowo fun gbigba atomiki/pilasima ni idapo.[Akiyesi—Ṣetan ojutu yii ni titun bi o ṣe nilo ni ọjọ lilo.]
Ojutu Apeere: Si 0.5 g ti Pramipexole Dihydrochloride ninu ọpọn iwọn didun 50-mL fi 5.00 milimita ti 1 M hydrochloric acid, ki o tu pẹlu alapapo.Dara si iwọn otutu yara, ki o si fomi pẹlu omi si iwọn didun.
Spectrometric ipo
(Wo Spectrophotometry ati Imọlẹ-Scattering 851).
Ipo: Atomic gbigba spectrophotometry
Iwo gigun atupale: Laini itujade Palladium ni 247.6 nm
Atupa: ṣofo cathode
Atomization orisun: Graphite ileru.[Akiyesi-Tẹle awọn ilana siseto ti olupese ṣe iṣeduro.]
Iwọn apẹẹrẹ: 20 µL
Òfo: Diluent
Ibamu eto
Apeere: Standard ojutu
Awọn ibeere ibamu
gbigba: NLT 0.034
Onínọmbà
Awọn apẹẹrẹ: Ojutu boṣewa ati ojutu Ayẹwo
Ṣe ipinnu ifọkansi ti palladium ninu ojutu Ayẹwo nipasẹ ọna afikun boṣewa.
Awọn ilana gbigba: NMT 5 ppm
Awọn ibeere afikun
• Iṣakojọpọ ati Ibi ipamọ: Fipamọ ni awọn apoti ti o ni pipade daradara, ti a daabobo lati ọrinrin ati ina.
• Awọn Ilana Itọkasi USP 11
USP Pramipexole Dihydrochloride RS Tẹ lati Wo Eto
USP Pramipexole Jẹmọ Agbo A RS
(S) -4,5,6,7-Tetrahydrobenzothiazole-2,6-diamine.
C7H11N3S 169.25
USP Pramipexole Jẹmọ Agbo D RS
(R) -2-Amino-4,5,6,7-tetrahydro-6- (propylamino) benzothiazole.
C10H17N3S 211.33
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H
Pramipexole Dihydrochloride Monohydrate (CAS: 191217-81-9) jẹ lilo
