Pramipexole Dihydrochloride Monohydrate CAS 191217-81-9 Assay 98.0 ~ 102.0%
I-Ruifu Chemical ngumenzi ohamba phambili wePramipexole Dihydrochloride Monohydrate (CAS: 191217-81-9) enomgangatho ophezulu.I-Ruifu Chemical inokubonelela ngenkonzo yehlabathi jikelele, ixabiso elikhuphisanayo, inkonzo egqwesileyo, encinci kunye nezixa ezininzi ezikhoyo.Thenga iPramipexole Dihydrochloride Monohydrate,Please contact: alvin@ruifuchem.com
| Igama leMchiza | Pramipexole Dihydrochloride Monohydrate |
| Izithethantonye | Pramipexole DiHCL Monohydrate;Pramipexole 2HCl Monohydrate;(S) -2-Amino-4,5,6,7-Tetrahydro-6-(Propylamino)benzothiazole Dihydrochloride Monohydrate |
| Ubume beStokhwe | Kwi-Stock, iMveliso yoRhwebo |
| Inombolo yeCAS | 191217-81-9 |
| CAS ezinxulumene | 104632-25-9 & 104632-26-0 |
| Ifomula yeemolekyuli | C10H17N3S·2HCl·H2O |
| Ubunzima beMolekyuli | 302.26 g/mol |
| Indawo yokunyibilika | 290℃(Disemba) |
| Ujikelezo oluKhethekileyo [a]20/D | -65.0 ° ukuya -71.0 ° (C=1 kwi-MeOH)(calcd.on anh.substance) |
| Ukunyibilika kwamanzi | Inyibilika emanzini |
| Ukunyibilika | Inyibilika kwiMethanol.I-Ethanol encinci kakhulu.Ayinyibiliki kwiDichloromethane |
| I-COA kunye ne-MSDS | Iyafumaneka |
| Imvelaphi | Shanghai, China |
| Uphawu | Ruifu Chemical |
| Izinto | Iinkcukacha | Iziphumo |
| Imbonakalo | Mhlophe ukuya kwi-Off-White Powder | Umgubo oMhlophe |
| Uvavanyo (nge-HPLC) | 98.0~102.0% | 99.34% |
| Amanzi nguKarl Fischer | 4.5~6.5% | Iyahambelana |
| Intsalela kwi-Ignition | ≤0.10% | <0.10% |
| Iintsimbi ezinzima (Pb) | ≤10ppm | <10ppm |
| Pramipexole Propionamidea | ≤0.15% | Iyahambelana |
| Pramipexole Related Compound A | ≤0.15% | Iyahambelana |
| N-Propylpramipexole | ≤0.15% | Iyahambelana |
| Pramipexole Dimer | ≤0.15% | Iyahambelana |
| Nakuphi na Okunye Ukungcola Komntu Ongachongwanga | ≤0.10% | Iyahambelana |
| Ucoceko lwe-Enantiomeric | ≤1.00% | Iyahambelana |
| I-Palladium | ≤5ppm | <5ppm |
| I-Infrared Spectrum | Ngokungqinelana noLwakhiwo | Iyahambelana |
| I-1H NMR Spectrum | Ngokungqinelana noLwakhiwo | Iyahambelana |
| Ukuqukumbela | Imveliso ivavanyiwe kwaye ihambelana neenkcukacha ezinikiweyo | |
Umqulu:Ibhotile eFluorinated, iAluminium foil bag, 25kg/Cardboard Drum, okanye ngokwemfuno yomthengi.
Imeko yoGcino:Gcina isikhongozeli sivalwe ngokuqinileyo kwaye usigcine kwindawo epholileyo, eyomileyo (2~8℃) kunye nendawo yokugcina impahla engena moya ikude kwizinto ezingahambelaniyo.Khusela ukukhanya kunye nokufuma.
Ukuhambisa ngenqanawe:Zisa kwihlabathi liphela ngomoya, ngeFedEx / DHL Express.Ukubonelela ngokukhawuleza nangokuthembekileyo.
C10H17N3S·2HCl·H2O 302.26
(S) -2-Amino-4,5,6,7-tetrahydro-6- (propylamino) benzothiazole dihydrochloride monohydrate [191217-81-9].
INGCACISO
I-Pramipexole Dihydrochloride iqulethe i-NLT 98.0% kunye ne-NMT 102.0% ye-C10H19Cl2N3S, ibalwe ngesiseko se-anhydrous.
UKUCHAZA
• A. I-Infrared Absorption <197A> okanye <197M>
Uluhlu lwenombolo yamaza: <197A>, 3800 cm-1 ukuya kwi-650 cm-1;<197M>, 4000 cm-1 ukuya kwi-600 cm-1
• B. Ixesha lokugcinwa kwencopho enkulu kwisisombululo seSampuli sihambelana nepramipexole (S-enantiomer) kwisisombululo sokufaneleka kweSistim ekuvavanyeni kwe-Enantiomeric Purity.
• C. Iimvavanyo zokuchonga Jikelele, iChloride <191>
Isampuli: 1 mg / mL yePramipexole Dihydrochloride emanzini
Iikhrayitheriya zokwamkelwa: Ihlangabezana neemfuno zovavanyo lwe-nitrate yesilivere yesilivere
UVAVANYO
• Inkqubo
Isisombululo A: Dissolve 9.1 g ye-potassium dihydrogen phosphate kunye ne-5.0 g ye-sodium 1-octanesulfonate monohydrate kwi-1 L yamanzi.Lungisa nge-asidi ye-phosphoric ukuya kwi-pH ye-3.0.
Isisombululo B: I-Acetonitrile kunye nesisombululo A (1:1)
I-Diluent: I-Acetonitrile kunye nesisombululo A (1:4)
Isigaba esiphathwayo: Bona itheyibhile yodidi olungezantsi.
Ixesha (min) Isisombululo A (%) Isisombululo B (%)
0 60 40
15 20 80
15.1 60 40
20 60 40
Isisombululo sokufaneleka kwenkqubo: 1.5 mg / mL ye-USP Pramipexole Dihydrochloride RS kunye ne-0.8 mg / mL ye-USP Pramipexole eNxulumene neCompound A RS kwi-Diluent
Isisombululo esisemgangathweni: 1.5 mg / mL ye-USP Pramipexole Dihydrochloride RS kwi-Diluent
Isisombululo sesampuli: 1.5 mg / mL yePramipexole Dihydrochloride kwi-Diluent
Inkqubo yeChromatographic
(Jonga iChromatography <621>, Ukufaneleka kweNkqubo.)
Indlela: LC
Umtshina: UV 264 nm
Ikholomu: 4.6-mm × 15-cm;5-µm ukupakisha i-L1
Ubushushu bekholamu: 40 ± 5
Izinga lokuhamba: 1.5 mL / min
Ubungakanani betofu: 5 µL
Ukufaneleka kwenkqubo
Iisampulu: Isisombululo sokufaneleka kweSistim kunye nesisombululo esiPhakathi [Qaphela-Amaxesha okugcinwa okuhambelana ne-pramipexole ehambelana nekhompawundi A kunye ne-pramipexole malunga ne-0.7 kunye ne-1.0, ngokulandelanayo.]
Iimfuno zokufaneleka
Isisombululo: NLT 6.0 phakathi kwe-pramipexole ehambelana nekhompawundi A kunye nepramipexole, isisombululo sokufaneleka kweNkqubo
Umba wokutsala: NMT 2.0 yepramipexole, isisombululo sokufaneleka kweSixokelelwano
Ukutenxa komgangatho ozalanayo: NMT 1.0%, isisombululo esisemgangathweni
Uhlalutyo
Iisampulu: Isisombululo esisemgangathweni kunye nesisombululo seSampuli
Bala ipesenti yeC10H19Cl2N3S kwinxalenye yePramipexole Dihydrochloride ethathiweyo:
Isiphumo = (rU/rS) × (CS/CU) × (Mr1/Mr2) × 100
rU = impendulo ephezulu evela kwiSampuli yesisombululo
rS = impendulo ephezulu evela kwisisombululo esiPhakathi
CS = ukuxinwa kwe-USP Pramipexole Dihydrochloride RS kwisisombululo esiPhakathi (mg / mL)
CU = ukuxinana kweSampuli yesisombululo (mg/mL)
UMnu1 = ubunzima bemolekyuli yepramipexole dihydrochloride, i-284.26
Mr2 = ubunzima bemolekyuli yepramipexole dihydrochloride monohydrate, 302.26
Indlela yokwamkela: 98.0% -102.0% kwisiseko se-anhydrous
UBUNGCOLA
Ukungcola Kwezinto Eziphilayo
• Intsalela ekulayiseni <281>: NMT 0.10%
• Iintsimbi ezinzima, Indlela I <231>
Isisombululo esisemgangathweni: Isisombululo esiPhambili seNkokheli, i-10 ppm
Isisombululo sesampuli: I-Ash 2 g ye-Pramipexole Dihydrochloride kude kube phantse yomile, ubunzima be-carbonized bufunyenwe.Pholisa intsalela, yongeza i-2.0 mL ye-nitric acid egxininisiweyo kunye ne-5 ye-concentrated sulfuric acid, kwaye uvumele ngononophelo ukuba i-fumes iguquke.Ukutshisa kwi-500-600 de i-carbon itshiswe ngokupheleleyo.Ukupholisa i-residu, yongeza i-4 mL ye-6 M i-hydrochloric acid, gubungela i-crucible, kwaye ugaye kwindawo yokuhlamba amanzi abilayo kwi-15 min.Umphunga ube komile.Yongeza ithontsi enye ye-hydrochloric acid egxininisiweyo kunye ne-10 mL yamanzi ashushu, kwaye ugaye enye i-2 min kwindawo yokuhlamba amanzi abilayo.Yongeza i-6 M yesisombululo se-ammonia kwi-dropwise de isisombululo sibe ne-alkaline ebuthakathaka, kwaye ulungelelanise ne-1 M acetic acid ukuya kwi-pH ye-3.0-4.0.Hlunga isisombululo kwi-flask ye-volumetric ye-25-mL, kwaye uhlambulule ngamanzi kwi-25 mL ngokuhlamba i-crucible kunye nesihluzo.
Indlela yolwamkelo: NMT 10 ppm
Ukungcola Okuphilayo
• Inkqubo
Isisombululo A, Isisombululo B, i-Diluent, isigaba se-Mobile, kunye nenkqubo ye-Chromatographic: Qhubeka njengoko kuyalelwe kwi-Assay.
Isisombululo sokufaneleka kwenkqubo: 7.5 µg/mL ye-USP Pramipexole Dihydrochloride RS kunye ne-3 µg/mL ye-USP Pramipexole eNxulumene neCompound A RS kwi-Diluent
Isisombululo esisemgangathweni: 1.5 µg/mL ye-USP Pramipexole Dihydrochloride RS kwiDiluent
Isisombululo sesampuli: 1.5 mg / mL yePramipexole Dihydrochloride kwi-Diluent
Ukufaneleka kwenkqubo
Iisampulu: Isisombululo sokufaneleka kwenkqubo kunye nesisombululo esiPhakathi
Iimfuno zokufaneleka
Isisombululo: NLT 6.0 phakathi kwe-pramipexole ehambelana nekhompawundi A kunye nepramipexole, isisombululo sokufaneleka kweNkqubo
Umba wokutsala: NMT 2.0 yepramipexole, isisombululo sokufaneleka kweSixokelelwano
Ukutenxa komgangatho ozalanayo: NMT 5.0%, isisombululo esisemgangathweni
Uhlalutyo
Iisampulu: Isisombululo esisemgangathweni kunye nesisombululo seSampuli
Bala ipesenteji yokungcola komntu kwinxalenye yePramipexole Dihydrochloride ethathiweyo:
Isiphumo = (rU/rS) × (CS/CU) × (Mr1/Mr2) × 100
I-rU = impendulo ephezulu yokungahlambuluki nganye kwisisombululo seSampuli
rS = impendulo ephezulu yepramipexole ukusuka kwisisombululo esiPhakathi
CS = ukuxinwa kwe-USP Pramipexole Dihydrochloride RS kwisisombululo esiPhakathi (mg / mL)
I-CU = i-concentration ye-pramipexole dihydrochloride monohydrate kwisisombululo seSampule (mg / mL)
UMnu1 = ubunzima bemolekyuli yepramipexole dihydrochloride, i-284.26
Mr2 = ubunzima bemolekyuli yepramipexole dihydrochloride monohydrate, 302.26
Iinqobo zokwamkelwa
Ukungcola komntu ngamnye: Jonga iTheyibhile yoku-1 yokungacoceki.
Ubumdaka bubonke: NMT 0.5%
Itheyibhile yokungcola 1
Igama Iinqobo zoKwamkelwa kweXesha loGcino, i-NMT (%)
I-Pramipexole propionamidea 0.5 0.15
Ikhompawundi enxulumene nePramipexole Ab 0.7 0.15
I-Pramipexole 1.0 -
N-Propylpramipexolec 1.4 0.15
Pramipexole dimerd 1.7 0.15
Nakuphi na okunye ukungcola komntu okungachazwanga — 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).Le yi-dimer ye-pramipexole (umxube wee-isomers ezine ezinokwenzeka).
IIMVAVANYO EZITHILE
• Ukumiselwa kwaManzi, iNdlela yoku-I <921>: i-NLT 4.5% kunye ne-NMT 6.5%
• I-Enantiomeric Purity
Isigaba seselula: i-n-Hexane, utywala obuphelelwe ngamanzi, kunye ne-diethylamine (850:150:1)
Inkqubo yokufaneleka kwesisombululo sesitokhwe: 1 mg / mL nganye ye-USP Pramipexole Dihydrochloride RS kunye ne-USP Pramipexole eNxulumene neCompound D RS kwi-alcohol dehydrated
Isisombululo sokufaneleka kweSistim: 0.01 mg / mL nganye ye-USP Pramipexole Dihydrochloride RS kunye ne-USP Pramipexole eNxulumene neCompound D RS ukusuka kwiSistim yesisombululo sesitokhwe kwisigaba seMobile
Isisombululo sesitokhwe esisemgangathweni: 2.0 mg / mL ye-USP Pramipexole eNxulumene neCompound D RS kwi-alcohol dehydrated
Isisombululo esisemgangathweni: 1.5 µg / mL ye-USP Pramipexole eNxulumene neCompound D RS kwisigaba seMobile
Isisombululo sesampuli: i-0.3 mg / mL, elungiselelwe ngokunyibilikisa ubungakanani obufanelekileyo obulinganisiweyo bePramipexole Dihydrochloride kwi-25% yomthamo weflask yotywala obuncitshisiweyo kunye nokuhlanjululwa kunye nesigaba se-Mobile ukuya kwivolumu
Inkqubo yeChromatographic
(Jonga iChromatography 621, Ukufaneleka kweNkqubo.)
Indlela: LC
Umtshina: UV 254 nm
Ikholomu: 4.6-mm × 25-cm;10-µm ukupakisha i-L51
Izinga lokuhamba: 1.5 mL / min
Ubungakanani besampulu: 75µL
Ukufaneleka kwenkqubo
Iisampulu: Isisombululo sokufaneleka kwenkqubo [Qaphela-Amaxesha okugcinwa okunxulumene nepramipexole enxulumene ne-D (R-enantiomer) kunye ne-pramipexole (S-enantiomer) yi-0.5 kunye ne-1.0, ngokulandelanayo.]
Iimfuno zokufaneleka
Isisombululo: I-NLT 5.0 phakathi kwe-pramipexole ehambelana nekhompawundi D kunye ne-pramipexole, isisombululo sokufaneleka kweNkqubo
Umba wokubala: I-NMT 2.4 yepramipexole, isisombululo sokufaneleka kweSixokelelwano
Uhlalutyo
Iisampulu: Isisombululo esisemgangathweni kunye nesisombululo seSampuli
Bala ipesenti ye-pramipexole ehambelana nekhompawundi D kwinxalenye yePramipexole Dihydrochloride ethathiweyo:
Isiphumo = (rU/rS) × (CS/CU) × 100
I-rU = impendulo ephezulu ye-pramipexole ehambelana ne-compound D ukusuka kwisisombululo seSampule
rS = impendulo ephezulu ye-pramipexole ehambelana nekhompawundi D ukusuka kwisisombululo esiPhakathi
I-CS = i-concentration ye-pramipexole ehambelana ne-compound D kwisisombululo esiPhakathi (mg/mL)
CU = ukuxinana kweSampuli yesisombululo (mg/mL)
Indlela yokwamkelwa: NMT 1.0% yepramipexole enxulumene nekhompawundi D
• Umda wePalladium
[Qaphela-Yenza olu vavanyo ukuba i-palladium yinto eyaziwayo yokungcola kwe-inorganic.]
I-Diluent: 0.1 M i-hydrochloric acid
Isisombululo esisemgangathweni: 40 µg/L yepalladium kwiDiluent, ukusuka kwisisombululo esisemgangathweni sepalladium esifumanekayo sorhwebo sokufunxwa kweathom/iplasma edityanisiweyo ngokungenisa.[Qaphela—Lungisa okutsha kwesi sisombululo njengoko kufuneka kusuku lokusetyenziswa.]
Isisombululo sesampuli: Kwi-0.5 g ye-Pramipexole Dihydrochloride kwi-flask ye-volumetric ye-50-mL yongeza i-5.00 mL ye-1 M i-hydrochloric acid, kwaye ichithe ngokufudumeza.Ukupholisa kwiqondo lokushisa, kwaye uhlambulule ngamanzi ukuya kwivolumu.
Iimeko zeSpectrometric
(Jonga i-Spectrophotometry kunye ne-Light-Scattering 851).
Imowudi: Ukufunxa i-atomic spectrophotometry
Ubude be-analytical waveleng: Umgca we-Palladium emission kwi-247.6 nm
Isibane: Cathode eHollow
Umthombo weAtomization: Iziko leGraphite.[Qaphela—Landela ulandelelwano lwenkqubo olucetyiswa ngumenzi.]
Ubungakanani besampulu: 20 µL
Akhonto: Diluent
Ukufaneleka kwenkqubo
Isampulu: Isisombululo esisemgangathweni
Iimfuno zokufaneleka
Ukungabikho: NLT 0.034
Uhlalutyo
Iisampulu: Isisombululo esisemgangathweni kunye nesisombululo seSampuli
Qinisekisa ukugxininiswa kwe-palladium kwisisombululo seSampuli ngendlela yokongeza eqhelekileyo.
Indlela yolwamkelo: NMT 5 ppm
IIMFUNO EZONGEZELELWEYO
• Ukupakisha kunye noGcino: Londoloza kwizikhongozeli ezivalwe kakuhle, zikhuselwe ekufuma nasekukhanyeni.
• ImiGangatho yeReferensi ye-USP 11
USP Pramipexole Dihydrochloride RS Cofa ukujonga iSakhiwo
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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I-Pramipexole Dihydrochloride Monohydrate (CAS: 191217-81-9) isetyenziswa
