Pramipexole Dihydrochloride Monohydrate CAS 191217-81-9 Assay 98.0~102.0%
Ruifu Chemical ke moetsi ea ka sehloohong oa Pramipexole Dihydrochloride Monohydrate (CAS: 191217-81-9) e nang le boleng bo phahameng.Ruifu Chemical e ka fana ka lits'ebeletso tsa lefats'e ka bophara, theko ea tlholisano, litšebeletso tse ntle haholo, tse nyane le tse ngata tse fumanehang.Reka Pramipexole Dihydrochloride Monohydrate,Please contact: alvin@ruifuchem.com
Lebitso la Lik'hemik'hale | Pramipexole Dihydrochloride Monohydrate |
Litlhaloso tse tšoanang | Pramipexole DiHCL Monohydrate;Pramipexole 2HCl Monohydrate;(S) -2-Amino-4,5,6,7-Tetrahydro-6-(Propylamino)benzothiazole Dihydrochloride Monohydrate |
Boemo ba Setoko | Ka Stock, Tlhahiso ea Khoebo |
Nomoro ea CAS | 191217-81-9 |
CAS e amanang le eona | 104632-25-9 & 104632-26-0 |
Foromo ea limolek'hule | C10H17N3S·2HCl·H2O |
Boima ba Molek'hule | 302.26 g/mol |
Melting Point | 290 ℃(Dec.) |
Phetoho e khethehileng [a]20/D | -65.0° ho ya ho -71.0° (C=1 ho MeOH)(calcd.on anh.substance) |
Ho qhibiliha ha Metsi | E qhibilihang ka Metsing |
Solubility | E qhibiliha ka Methanol.Ethanol e nyane haholo.Ha e qhibilihe ka har'a Dichloromethane |
COA & MSDS | E fumaneha |
Tšimoloho | Shanghai, China |
Brand | Ruifu Chemical |
Lintho | Litlhaloso | Liphetho |
Ponahalo | Phofo e tšoeu ho isa ho e tšoeu | Phofo e Tshweu |
Assay (ka HPLC) | 98.0~102.0% | 99.34% |
Metsi ka Karl Fischer | 4.5~6.5% | E lumellana |
Masalla a ho Ignition | ≤0.10% | <0.10% |
Litšepe tse boima (Pb) | ≤10ppm | <10ppm |
Pramipexole Propionamidea | ≤0.15% | E lumellana |
Pramipexole Related Compound A | ≤0.15% | E lumellana |
N-Propylpramipexole | ≤0.15% | E lumellana |
Pramipexole Dimer | ≤0.15% | E lumellana |
Tšilafalo E 'ngoe E 'ngoe e sa Tsejoeng ea Motho ka Mong | ≤0.10% | E lumellana |
Enantiomeric Bohloeki | ≤1.00% | E lumellana |
Palladium | ≤5ppm | <5ppm |
Infrared Spectrum | E tsamaellanang le Sebopeho | E lumellana |
1H NMR Spectrum | E tsamaellanang le Sebopeho | E lumellana |
Qetello | Sehlahisoa se lekoa 'me se lumellana le litlhaloso tse fanoeng |
Sephutheloana:Botlolo ea Fluorinated, Aluminium foil bag, 25kg/Cardboard Drum, kapa ho latela tlhoko ea moreki.
Boemo ba polokelo:Boloka setshelo se kwetswe ka thata mme o se boloke sebakeng se phodileng, se omeletseng (2~8℃) le se nang le moya o hlwekileng hole le dintho tse sa dumellaneng.Sireletsa leseli le mongobo.
Ho tsamaisa ka sekepe:Tsamaisa lefatšeng ka bophara ka sefofane, ka FedEx / DHL Express.Fana ka thomello e potlakileng le e tšepahalang.
C10H17N3S·2HCl·H2O 302.26
(S) -2-Amino-4,5,6,7-tetrahydro-6- (propylamino) benzothiazole dihydrochloride monohydrate [191217-81-9].
TLHALOSO
Pramipexole Dihydrochloride e na le NLT 98.0% le NMT 102.0% ea C10H19Cl2N3S, e baloang motheong oa anhydrous.
TS'ELISO TS'OANE
• A. Infrared Absorption <197A> kapa <197M>
Leqhubu la palo ea maqhubu: <197A>, 3800 cm-1 ho 650 cm-1;<197M>, 4000 cm-1 ho isa ho 600 cm-1
• B. Nako ea ho boloka tlhōrō ea tlhōrō e kholo ea Sample tharollo e lumellana le ea pramipexole (S-enantiomer) ka har'a tharollo ea ho tšoaneleha ha System tekong ea Enantiomeric Purity.
• C. Liteko tsa Boitsebiso-Kakaretso, Chloride <191>
Mohlala: 1 mg / mL ea Pramipexole Dihydrochloride ka metsing
Mekhoa ea ho amohela: E finyella litlhoko tsa tlhahlobo ea silver nitrate precipitate
TLHOKOMELO
• Tsamaiso
Tharollo A: Hlakola 9.1 g ya potassium dihydrogen phosphate le 5.0 g ya sodium 1-octanesulfonate monohydrate ka 1 L ea metsi.Fetola ka asiti ya phosphoric ho pH ya 3.0.
Tharollo B: Acetonitrile le Tharollo A (1:1)
Diluent: Acetonitrile le Tharollo A (1:4)
Mohato oa Mobile: Sheba tafole ea gradient e ka tlase.
Nako (metsotso) Tharollo A (%) Tharollo B (%)
06040
15 20 80
15.1 60 40
20 60 40
Tharollo e loketseng ea tsamaiso: 1.5 mg/mL ea USP Pramipexole Dihydrochloride RS le 0.8 mg/mL ea USP Pramipexole Related Compound A RS in Diluent
Tharollo e tloaelehileng: 1.5 mg/mL ea USP Pramipexole Dihydrochloride RS in Diluent
Tharollo ea mohlala: 1.5 mg / mL ea Pramipexole Dihydrochloride ka Diluent
Sistimi ea chromatographic
(Sheba Chromatography <621>, Ho Hlokahala Sistimi.)
Mokhoa: LC
Sesebelisoa: UV 264 nm
Kholomo: 4.6-mm × 15-cm;5-µm e paka L1
Mocheso oa kholomo: 40 ± 5
Sekhahla sa phallo: 1.5 mL / min
Boholo ba ente: 5 µL
Ho nepahala ha sistimi
Mehlala: Tharollo ea ho tšoaneleha ha Sistimi le Tharollo e Tloaelehileng [Hlokomela-Linako tse lekanyelitsoeng tsa ho boloka motsoako oa pramipexole o amanang le A le pramipexole ke hoo e ka bang 0.7 le 1.0, ka ho latellana.]
Litlhoko tsa ho tšoaneleha
Qeto: NLT 6.0 pakeng tsa motsoako o amanang le pramipexole A le pramipexole, tharollo ea ho tšoaneleha ha Sisteme
Ntlha ea bohlokoa: NMT 2.0 bakeng sa pramipexole, Tharollo ea ho tšoaneleha ha Sisteme
Phapang e amanang le maemo: NMT 1.0%, Tharollo e tloaelehileng
Tlhahlobo
Mehlala: Tharollo e tloaelehileng le Tharollo ea Mohlala
Bala peresente ea C10H19Cl2N3S karolong ea Pramipexole Dihydrochloride e nkiloeng:
Sephetho = (rU/rS) × (CS/CU) × (Mr1/Mr2) × 100
rU = karabelo e phahameng ho tsoa ho Sample solution
rS = karabelo ea tlhōrō ho tsoa ho tharollo e tloaelehileng
CS = mahloriso a USP Pramipexole Dihydrochloride RS ka tharollo e tloaelehileng (mg/mL)
CU = mahloriso a tharollo ea Mohlala (mg/mL)
Mr1 = boima ba molek'hule ea pramipexole dihydrochloride, 284.26
Mr2 = boima ba molek'hule ea pramipexole dihydrochloride monohydrate, 302.26
Mekhoa ea ho amohela: 98.0% -102.0% motheong oa anhydrous
LITŠILA
Tšilafalo ea Inorganic
• Masalla a ho Ignition <281>: NMT 0.10%
• Metals e boima, Mokhoa oa I <231>
Tharollo e tloaelehileng: Tharollo e Tloaelehileng ea Moeta-pele, 10 ppm
Mohlala oa tharollo: Molora 2 g oa Pramipexole Dihydrochloride ho fihlela boima bo batlang bo omme, bo nang le carbonized bo fumanoa.Pholisa masalla, eketsa 2.0 mL ea concentrated nitric acid le marotholi a 5 a concentrated sulfuric acid, 'me ka hloko u lumelle mosi hore o fetohe.Hotetsa ho 500-600 ho fihlela carbon e chesitsoe ka ho feletseng.Pholisa masala, eketsa 4 mL ea 6 M hydrochloric acid, koahela crucible, 'me u sile ka bateng ea metsi a belang bakeng sa 15 min.Moafala ho omella.Eketsa lerotholi le le leng la concentrated hydrochloric acid le 10 mL ea metsi a chesang, 'me u chese metsotso e meng ea 2 ka bateng ea metsi a belang.Eketsa 6 M ammonia solution dropwise ho fihlela tharollo e le alkaline e fokolang, 'me u ikamahanya le 1 M acetic acid ho pH ea 3.0–4.0.Sefa tharollo ka botlolo ea volumetric ea 25-mL, 'me u hlapolle ka metsi ho 25mL ka ho hlatsoa crucible le sefe.
Maemo a kamohelo: NMT 10 ppm
Litšila tsa Organic
• Tsamaiso
Tharollo A, Tharollo B, Diluent, Mobile phase, le tsamaiso ea Chromatographic: Tsoela pele joalokaha ho laetsoe ho Assay.
Tharollo e loketseng tsamaiso: 7.5 µg/mL ea USP Pramipexole Dihydrochloride RS le 3 µg/mL ea USP Pramipexole Related Compound A RS in Diluent
Tharollo e tloaelehileng: 1.5 µg/mL ea USP Pramipexole Dihydrochloride RS ka Diluent
Tharollo ea mohlala: 1.5 mg / mL ea Pramipexole Dihydrochloride ka Diluent
Ho nepahala ha sistimi
Mehlala: Tharollo ea ho tšoaneleha ha Sisteme le tharollo e Tloaelehileng
Litlhoko tsa ho tšoaneleha
Qeto: NLT 6.0 pakeng tsa motsoako o amanang le pramipexole A le pramipexole, tharollo ea ho tšoaneleha ha Sisteme
Ntlha ea bohlokoa: NMT 2.0 bakeng sa pramipexole, Tharollo ea ho tšoaneleha ha Sisteme
Phapang e amanang le maemo: NMT 5.0%, Tharollo e tloaelehileng
Tlhahlobo
Mehlala: Tharollo e tloaelehileng le Tharollo ea Mohlala
Bala liperesente tsa ho se hloeke ha motho ka mong karolong ea Pramipexole Dihydrochloride e nkiloeng:
Sephetho = (rU/rS) × (CS/CU) × (Mr1/Mr2) × 100
rU = tlhōrō ea karabo ea ho se hloeke ka 'ngoe ho tsoa ho Sample solution
rS = karabelo e phahameng ea pramipexole ho tsoa ho tharollo e tloaelehileng
CS = mahloriso a USP Pramipexole Dihydrochloride RS ka tharollo e tloaelehileng (mg/mL)
CU = mahloriso a pramipexole dihydrochloride monohydrate ho Sample solution (mg/mL)
Mr1 = boima ba molek'hule ea pramipexole dihydrochloride, 284.26
Mr2 = boima ba molek'hule ea pramipexole dihydrochloride monohydrate, 302.26
Mekhoa ea ho amohela
Litšila tsa motho ka mong: Sheba Lethathamo la 1 la Tšilafalo.
Kakaretso ea litšila: NMT 0.5%
Lethathamo la 1 la Tšilafalo
Bolela Maemo a Kamohelo a Nako ea ho Boloka Nako, NMT (%)
Pramipexole propionamidea 0.5 0.15
Motsoako o amanang le Pramipexole Ab 0.7 0.15
Pramipexole 1.0 -
N-Propylpramipexolec 1.4 0.15
Pramipexole dimerd 1.7 0.15
Tšilafalo efe kapa efe e sa tsejoeng ea motho ka mong - 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).Ena ke dimer ea pramipexole (motsoako oa li-isomers tse 'nè tse ka khonehang).
LITEKO TSEKO
• Boikemisetso ba Metsi, Mokhoa oa I <921>: NLT 4.5% le NMT 6.5%
• Enantiomeric Bohloeki
Mohato oa mobile: n-Hexane, joala bo se nang metsi, le diethylamine (850:150:1)
Sistimi e loketseng tharollo ea stock: 1 mg/mL e 'ngoe le e' ngoe ea USP Pramipexole Dihydrochloride RS le USP Pramipexole Related Compound D RS ka joala bo se nang metsi
Tharollo ea ts'ebetso ea tsamaiso: 0.01 mg / mL e 'ngoe le e' ngoe ea USP Pramipexole Dihydrochloride RS le USP Pramipexole Related Compound D RS ho tloha ho System suitability stock solution in Mobile phase
Tharollo e tloaelehileng ea setoko: 2.0 mg/mL ea USP Pramipexole Related Compound D RS ka joala bo se nang metsi
Tharollo e tloaelehileng: 1.5 µg/mL ea USP Pramipexole Related Compound D RS in Mobile phase
Tharollo ea mohlala: 0.3 mg/mL, e lokiselitsoeng ka ho qhala tekanyo e lekantsoeng ea Pramipexole Dihydrochloride ka 25% ea bolumo ea botlolo ea joala bo se nang metsi le ho hlapolloa ka Mobile phase ho ea bophahamong.
Sistimi ea chromatographic
(Sheba Chromatography 621, Ho Hlokahala Sistimi.)
Mokhoa: LC
Sesebelisoa: UV 254 nm
Kholomo: 4.6-mm × 25-cm;10-µm e paka L51
Sekhahla sa phallo: 1.5 mL / min
Saese ea mohlala: 75µL
Ho nepahala ha sistimi
Mehlala: Tharollo ea ho tšoaneleha ha Sistimi [Hlokomela-Linako tse lekanyelitsoeng tsa ho boloka motsoako oa pramipexole o amanang le D (R-enantiomer) le pramipexole (S-enantiomer) ke 0.5 le 1.0, ka ho latellana.]
Litlhoko tsa ho tšoaneleha
Qeto: NLT 5.0 pakeng tsa motsoako o amanang le pramipexole D le pramipexole, tharollo ea ho tšoaneleha ha Sisteme
Ntlha ea bohlokoa: NMT 2.4 bakeng sa pramipexole, Tharollo ea ho tšoaneleha ha Sisteme
Tlhahlobo
Mehlala: Tharollo e tloaelehileng le Tharollo ea Mohlala
Bala liperesente tsa motsoako o amanang le pramipexole D karolong ea Pramipexole Dihydrochloride e nkiloeng:
Sephetho = (rU/rS) × (CS/CU) × 100
rU = karabelo ea tlhōrō ea motsoako o amanang le pramipexole D ho tsoa ho Sample solution
rS = karabelo ea tlhōrō ea motsoako o amanang le pramipexole D ho tsoa ho tharollo e tloaelehileng
CS = mahloriso a motsoako o amanang le pramipexole D ka tharollo e tloaelehileng (mg/mL)
CU = mahloriso a tharollo ea Mohlala (mg/mL)
Mokhoa oa ho amohela: NMT 1.0% ea motsoako o amanang le pramipexole D
• Moeli oa Palladium
[Hlokomela-Etsa tlhahlobo ena haeba palladium e le litšila tse tsebahalang.]
Mokelikeli: 0.1 M hydrochloric acid
Tharollo e tloaelehileng: 40 µg/L ea palladium ho Diluent, ho tsoa ho tharollo e tloaelehileng ea palladium e fumanehang khoebong bakeng sa ho monya atomic/plasma e kopantsoeng ka mokhoa o ikhethileng.[Tlhokomeliso—Lokisetsa tharollo ena bocha ha ho hlokahala ka letsatsi la tšebeliso.]
Tharollo ea mohlala: Ho 0.5 g ea Pramipexole Dihydrochloride ka botlolo ea volumetric ea 50-mL eketsa 5.00 mL ea 1 M hydrochloric acid, 'me u qhale ka ho futhumatsa.Pholile ho mocheso oa kamore, 'me u hlapolle ka metsi ho ea bophahamong.
Maemo a spectrometric
(Sheba Spectrophotometry le Light-Sscattering 851).
Mokhoa: spectrophotometry ea ho monya atomic
Analytical wavelength: Palladium emission line ho 247.6 nm
Lebone: Hollow cathode
Mohloli oa atomization: Sebōpi sa Graphite.[Ela hloko—Latela tatelano e khothaletsoang ea moetsi.]
Saese ea mohlala: 20µL
Qeto: E hloekile
Ho nepahala ha sistimi
Mohlala: Tharollo e tloaelehileng
Litlhoko tsa ho tšoaneleha
Ho se be teng: NLT 0.034
Tlhahlobo
Mehlala: Tharollo e tloaelehileng le Tharollo ea Mohlala
Etsa qeto ea bongata ba palladium ka har'a tharollo ea Mohlala ka mokhoa o tloaelehileng oa ho eketsa.
Maemo a kamohelo: NMT 5 ppm
KEKELETSO LIHLOKO
• Sephutheloana le ho Boloka: Boloka ka lijaneng tse koetsoeng hantle, tse sirelelitsoeng mongobo le khanya.
• USP Reference Standards 11
USP Pramipexole Dihydrochloride RS Tobetsa ho Sheba Sebopeho
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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Pramipexole Dihydrochloride Monohydrate (CAS: 191217-81-9) e sebelisoa