Tom ntej: Pramipexole Dihydrochloride Monohydrate CAS 191217-81-9 Assay 98.0 ~ 102.0%
Ruifu Chemical yog cov chaw tsim khoom ntawm Pramipexole Dihydrochloride Monohydrate (CAS: 191217-81-9) nrog cov khoom zoo.Ruifu Chemical tuaj yeem muab kev xa khoom thoob ntiaj teb, tus nqi sib tw, kev pabcuam zoo heev, me me thiab ntau ntau muaj.Yuav Pramipexole Dihydrochloride Monohydrate,Please contact: alvin@ruifuchem.com
| Tshuaj npe | Pramipexole Dihydrochloride Monohydrate |
| Synonyms | Pramipexole DiHCL Monohydrate;Pramipexole 2HCl Monohydrate;(S)-2-Amino-4,5,6,7-Tetrahydro-6-(Propylamino) benzothiazole Dihydrochloride Monohydrate |
| Tshuag xwm txheej | Hauv Tshuag, Kev Lag Luam Ntau Lawm |
| CAS Nr | 191217-81-9 |
| Related CAS | 104632-25-9 & 104632-26-0 |
| Molecular Formula | C10H17N3S · 2HCl · H2O |
| Molecular Luj | 302.26 g / mol |
| Melting Point | 290 ℃ (txog.) |
| Kev sib hloov tshwj xeeb [a]20/D | -65.0° to -71.0° (C = 1 in MeOH)(calcd.on anh.substance) |
| Dej Solubility | Soluble hauv dej |
| Solubility | Soluble hauv Methanol.Heev me ntsis Ethanol.Insoluble hauv Dichloromethane |
| COA & MSDS | Muaj |
| Keeb kwm | Shanghai, Suav |
| Hom | Ruifu Tshuaj |
| Cov khoom | Specifications | Cov txiaj ntsig |
| Qhov tshwm sim | Dawb rau Off-White Powder | Dawb hmoov |
| Assay (los ntawm HPLC) | 98.0 ~ 102.0% | 99.34% |
| Dej los ntawm Karl Fischer | 4.5 ~ 6.5% | Ua raws |
| Residue ntawm Ignition | ≤0.10% | <0.10% |
| Heavy Metals (Pb) | ≤10ppm | <10ppm |
| Pramipexole Propionamidea | ≤ 0.15% | Ua raws |
| Pramipexole Related Compound A | ≤ 0.15% | Ua raws |
| N-Propylpramipexole | ≤ 0.15% | Ua raws |
| Pramipexole Dimer | ≤ 0.15% | Ua raws |
| Lwm Yam Tsis Muaj Tus Kheej Tus Kheej Impurity | ≤0.10% | Ua raws |
| Enantiomeric Purity yog qhov zoo | ≤ 1.00% | Ua raws |
| Palladium | ≤ 5ppm | <5 ppm |
| Infrared Spectrum | Raws li tus qauv | Ua raws |
| 1 H NMR Spectrum | Raws li tus qauv | Ua raws |
| Xaus | Cov khoom tau raug kuaj thiab ua raws li cov lus qhia tshwj xeeb | |
Pob:Fluorinated Lub raj mis, Aluminium ntawv ci hnab, 25kg / Cardboard Nruas, lossis raws li cov neeg siv khoom xav tau.
Cia txias:Khaws lub thawv kaw kom nruj thiab khaws cia rau hauv qhov chaw txias, qhuav (2 ~ 8 ℃) thiab lub tsev tso cua txias kom deb ntawm cov khoom tsis sib xws.Tiv thaiv los ntawm lub teeb thiab noo noo.
Shipping:Xa mus thoob ntiaj teb los ntawm huab cua, los ntawm FedEx / DHL Express.Muab kev xa khoom sai thiab txhim khu kev qha.
C10H17N3S · 2HCl · H2O 302.26
(S)-2-Amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate [191217-81-9].
DEFINITION
Pramipexole Dihydrochloride muaj NLT 98.0% thiab NMT 102.0% ntawm C10H19Cl2N3S, xam los ntawm lub hauv paus anhydrous.
IDENTIFICATION
• A. Infrared Absorption <197A> lossis <197M>
Wave naj npawb: <197A>, 3800 cm-1 txog 650 cm-1;<197M>, 4000 cm-1 txog 600 cm-1
• B. Lub sij hawm khaws cia ntawm lub ncov loj hauv cov qauv kev daws teeb meem sib raug rau cov pramipexole (S-enantiomer) hauv System suitability tov nyob rau hauv qhov kev xeem rau Enantiomeric Purity.
• C. Identification Tests-General, Chloride <191>
Qauv: 1 mg / mL ntawm Pramipexole Dihydrochloride hauv dej
Kev lees txais cov qauv: Ua tau raws li qhov yuav tsum tau ua ntawm cov nyiaj nitrate precipitate test
QHIA
• Cov txheej txheem
Kev daws A: Dissolve 9.1 g ntawm poov tshuaj dihydrogen phosphate thiab 5.0 g ntawm sodium 1-octanesulfonate monohydrate hauv 1 L dej.Kho nrog phosphoric acid rau pH ntawm 3.0.
Tshuaj B: Acetonitrile thiab tshuaj A (1: 1)
Diluent: Acetonitrile thiab Solution A (1:4)
Mobile theem: Saib lub gradient table hauv qab no.
Sijhawm (min) Kev daws A (%) Kev daws B (%)
0 6040
15 2080 ib
15.160 40 Nws
20 6040
Kev daws teeb meem tsim nyog: 1.5 mg / mL ntawm USP Pramipexole Dihydrochloride RS thiab 0.8 mg / mL ntawm USP Pramipexole Related Compound A RS hauv Diluent
Kev daws teeb meem: 1.5 mg / mL ntawm USP Pramipexole Dihydrochloride RS hauv Diluent
Cov qauv tshuaj: 1.5 mg / mL ntawm Pramipexole Dihydrochloride hauv Diluent
Chromatographic system
(Saib Chromatography <621>, System Suitability.)
Qauv: LC
Detector: UV 264 nm
Kem: 4.6-mm × 15-cm;5-µm ntim L1
Kem kub: 40 ± 5
Tus nqi ntws: 1.5 mL / min
Kev txhaj tshuaj loj: 5 µL
Qhov system haum
Cov Qauv: Cov kev daws teeb meem tsim nyog thiab cov qauv kev daws teeb meem [Ceeb toom-Lub sijhawm khaws cov txheeb ze rau pramipexole ntsig txog compound A thiab pramipexole yog kwv yees li 0.7 thiab 1.0, feem.]
Suitability xav tau
Kev daws teeb meem: NLT 6.0 ntawm pramipexole ntsig txog compound A thiab pramipexole, Kev daws teeb meem tsim nyog
Tailing yam: NMT 2.0 rau pramipexole, System suitability tov
Tus qauv sib txawv: NMT 1.0%, Standard tov
Kev tsom xam
Qauv: Cov qauv kev daws teeb meem thiab cov qauv kev daws teeb meem
Xam qhov feem pua ntawm C10H19Cl2N3S hauv feem ntawm Pramipexole Dihydrochloride noj:
Result = (rU/rS) × (CS/CU) × (Mr1/Mr2) × 100
rU = ncov teb los ntawm Sample tov
rS = ncov teb los ntawm Standard tov
CS = concentration ntawm USP Pramipexole Dihydrochloride RS nyob rau hauv Standard tov (mg / mL)
CU = concentration of the Sample solution (mg/mL)
Mr1 = molecular hnyav ntawm pramipexole dihydrochloride, 284.26
Mr2 = molecular hnyav ntawm pramipexole dihydrochloride monohydrate, 302.26
Kev lees txais cov qauv: 98.0% -102.0% ntawm lub hauv paus anhydrous
IMPURITIES
Inorganic impurities
• Residue ntawm Ignition <281>: NMT 0.10%
• Heavy Metals, Method I <231>
Kev daws teeb meem: Standard Lead Solution, 10 ppm
Qauv tov: tshauv 2 g ntawm Pramipexole Dihydrochloride kom txog thaum yuav luag qhuav, carbonized loj tau txais.Txias cov seem, ntxiv 2.0 mL ntawm concentrated nitric acid thiab 5 tee ntawm concentrated sulfuric acid, thiab ua tib zoo tso cov pa tawm mus.Ignite ntawm 500-600 kom txog thaum cov pa roj carbon hlawv tag.Txias cov residue, ntxiv 4 mL ntawm 6 M hydrochloric acid, npog lub crucible, thiab zom rau ntawm boiling dej da dej rau 15 feeb.Evaporate rau dryness.Ntxiv ib tee ntawm concentrated hydrochloric acid thiab 10 mL ntawm dej kub, thiab zom rau 2 feeb ntxiv rau ntawm lub boiling dej da dej.Ntxiv 6 M ammonia tshuaj dropwise kom txog thaum cov tshuaj tsis muaj zog alkaline, thiab kho nrog 1 M acetic acid rau pH ntawm 3.0-4.0.Lim cov tshuaj rau hauv 25-mL volumetric hwj, thiab dilute nrog dej mus rau 25 mL los ntawm kev ntxuav lub crucible thiab lim.
Kev lees txais: NMT 10 ppm
Organic impurities
• Cov txheej txheem
Kev daws A, Kev daws B, Diluent, Mobile theem, thiab Chromatographic system: Ua raws li tau hais hauv Kev Tshawb Fawb.
Kev daws teeb meem tsim nyog: 7.5 µg / mL ntawm USP Pramipexole Dihydrochloride RS thiab 3 µg / mL ntawm USP Pramipexole Related Compound A RS hauv Diluent
Kev daws teeb meem: 1.5 µg / mL ntawm USP Pramipexole Dihydrochloride RS hauv Diluent
Cov qauv tshuaj: 1.5 mg / mL ntawm Pramipexole Dihydrochloride hauv Diluent
Qhov system haum
Qauv: Kev daws teeb meem tsim nyog thiab kev daws teeb meem
Suitability xav tau
Kev daws teeb meem: NLT 6.0 ntawm pramipexole ntsig txog compound A thiab pramipexole, Kev daws teeb meem tsim nyog
Tailing yam: NMT 2.0 rau pramipexole, System suitability tov
Tus qauv sib txawv: NMT 5.0%, Standard tov
Kev tsom xam
Qauv: Cov qauv kev daws teeb meem thiab cov qauv kev daws teeb meem
Xam cov feem pua ntawm ib tus neeg impurity hauv feem ntawm Pramipexole Dihydrochloride noj:
Result = (rU/rS) × (CS/CU) × (Mr1/Mr2) × 100
rU = ncov teb ntawm txhua impurity los ntawm cov qauv tov
rS = ncov teb ntawm pramipexole los ntawm Standard tov
CS = concentration ntawm USP Pramipexole Dihydrochloride RS nyob rau hauv Standard tov (mg / mL)
CU = concentration ntawm pramipexole dihydrochloride monohydrate nyob rau hauv cov qauv tov (mg / mL)
Mr1 = molecular hnyav ntawm pramipexole dihydrochloride, 284.26
Mr2 = molecular hnyav ntawm pramipexole dihydrochloride monohydrate, 302.26
Kev lees txais
Ib tug neeg impurities: Saib Impurity Table 1.
Tag nrho impurities: NMT 0.5%
Impurity Table 1
Lub Npe Lub Sijhawm Retention Lub Sijhawm Txais Txais, NMT (%)
Pramipexole propionamidea 0.5 0.15
Pramipexole related compound Ab 0.7 0.15
Pramipexole 1.0 -
N-Propylpramipexolec 1.4 0.15
Pramipexole dimerd 1.7 0.15
Lwm tus neeg tsis paub txog qhov tsis huv - 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).Qhov no yog ib qho dimer ntawm pramipexole (ib qho sib xyaw ntawm plaub lub isomers).
TSEEM CEEB
• Kev Txiav Txim Dej, Txoj Kev I <921>: NLT 4.5% thiab NMT 6.5%
• Enantiomeric Purity
Mobile theem: n-Hexane, dej cawv, thiab diethylamine (850: 150: 1)
Cov khoom tsim nyog cov tshuaj: 1 mg / mL txhua ntawm USP Pramipexole Dihydrochloride RS thiab USP Pramipexole Related Compound D RS hauv dej cawv
Kev daws teeb meem tsim nyog: 0.01 mg / mL txhua ntawm USP Pramipexole Dihydrochloride RS thiab USP Pramipexole Related Compound D RS los ntawm System suitability stock solution nyob rau theem txawb
Standard Tshuag tov: 2.0 mg / mL ntawm USP Pramipexole Related Compound D RS nyob rau hauv lub cev qhuav dej cawv
Kev daws teeb meem: 1.5 µg / mL ntawm USP Pramipexole Related Compound D RS nyob rau theem txawb
Piv txwv li: 0.3 mg / mL, npaj los ntawm dissolving ib tug haum hnyav npaum li cas ntawm Pramipexole Dihydrochloride nyob rau hauv 25% ntawm ib khob ntim ntawm lub cev qhuav dej cawv thiab diluting nrog Mobile theem mus ntim
Chromatographic system
(Saib Chromatography 621, System Suitability.)
Qauv: LC
Detector: UV 254 nm
Kem: 4.6-mm × 25-cm;10-µm ntim L51
Tus nqi ntws: 1.5 mL / min
Qauv Loj: 75 µL
Qhov system haum
Cov Qauv: Cov kev daws teeb meem tsim nyog [Nco tseg-Lub sijhawm khaws cov txheeb ze rau pramipexole ntsig txog cov khoom sib xyaw D (R-enantiomer) thiab pramipexole (S-enantiomer) yog 0.5 thiab 1.0, feem.]
Suitability xav tau
Kev daws teeb meem: NLT 5.0 ntawm pramipexole ntsig txog compound D thiab pramipexole, Kev daws teeb meem tsim nyog
Tailing yam: NMT 2.4 rau pramipexole, System haum haum
Kev tsom xam
Qauv: Cov qauv kev daws teeb meem thiab cov qauv kev daws teeb meem
Xam cov feem pua ntawm pramipexole muaj feem xyuam nrog D hauv feem ntawm Pramipexole Dihydrochloride noj:
Result = (rU/rS) × (CS/CU) × 100
rU = ncov teb ntawm pramipexole ntsig txog compound D los ntawm cov qauv tshuaj
rS = ncov teb ntawm pramipexole ntsig txog compound D los ntawm Standard tov
CS = concentration ntawm pramipexole ntsig txog compound D nyob rau hauv Standard tov (mg / mL)
CU = concentration of the Sample solution (mg/mL)
Kev lees txais cov qauv: NMT 1.0% ntawm pramipexole ntsig txog compound D
• Txwv ntawm Palladium
[Ceeb toom-Ua qhov kev sim no yog tias palladium yog ib qho paub tsis zoo hauv cov khoom tsis huv.]
Diluent: 0.1 M hydrochloric acid
Kev daws teeb meem: 40 µg / L ntawm palladium hauv Diluent, los ntawm cov khoom lag luam muaj palladium tus qauv tshuaj rau atomic absorption / inductively coupled plasma.[Ceeb Toom—Freshly npaj cov tshuaj no raws li qhov xav tau ntawm hnub siv.]
Piv txwv li: Rau 0.5 g ntawm Pramipexole Dihydrochloride nyob rau hauv 50-mL volumetric hwj ntxiv 5.00 mL ntawm 1 M hydrochloric acid, thiab yaj nrog cua sov.Txias mus rau chav tsev kub, thiab dilute nrog dej rau ntim.
Spectrometric tej yam kev mob
(Saib Spectrophotometry thiab Light-Scattering 851).
Hom: Atomic absorption spectrophotometric
Analytical wavelength: Palladium emission kab ntawm 247.6 nm
Lub teeb: Hollow cathode
Atomization qhov chaw: Graphite rauv.[Ceeb Toom—Ua raws li cov chaw tsim khoom pom zoo cov txheej txheem ua ntu zus.]
Qauv Loj: 20 µL
Dawb: Diluent
Qhov system haum
Qauv: Standard tov
Suitability xav tau
Absorbance: NLT 0.034
Kev tsom xam
Qauv: Cov qauv kev daws teeb meem thiab cov qauv kev daws teeb meem
Txiav txim siab qhov concentration ntawm palladium hauv cov qauv kev daws teeb meem los ntawm cov txheej txheem ntxiv.
Kev lees txais: NMT 5 ppm
TSEEM CEEB
• Ntim thiab Cia: Khaws rau hauv cov thawv kaw kom zoo, tiv thaiv los ntawm ya raws thiab lub teeb.
• USP Reference Standards 11
USP Pramipexole Dihydrochloride RS Nyem rau Saib Cov Qauv
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
Pramipexole Dihydrochloride Monohydrate (CAS: 191217-81-9) yog siv
