Pramipexole Dihydrochloride Monohydrate CAS 191217-81-9 Assay 98.0~102.0%
Ko Ruifu Chemical te kaihanga matua o Pramipexole Dihydrochloride Monohydrate (CAS: 191217-81-9) me te kounga teitei.Ka taea e Ruifu Chemical te tuku i te ao, te utu whakataetae, te ratonga pai, te iti me te rahinga e waatea ana.Hokona Pramipexole Dihydrochloride Monohydrate,Please contact: alvin@ruifuchem.com
| Ingoa matū | Pramipexole Dihydrochloride Monohydrate |
| Nga kupu taurite | Pramipexole DiHCL Monohydrate;Pramipexole 2HCl Monohydrate;(S)-2-Amino-4,5,6,7-Tetrahydro-6-(Propylamino)benzothiazole Dihydrochloride Monohydrate |
| Tūnga Taonga | I roto i te Stock, Production Arumoni |
| Tau CAS | 191217-81-9 |
| CAS e pa ana | 104632-25-9 & 104632-26-0 |
| Tātai rāpoi | C10H17N3S·2HCl·H2O |
| Taumaha rāpoi | 302.26 g/mol |
| Iwi Whakarewa | 290℃(tikuri) |
| Hurihuri Tau [a]20/D | -65.0° ki te -71.0° (C=1 i roto i te MeOH)(calcd.on anh.substance) |
| Wairewa wai | Wairewa ki te wai |
| Wairewa | Wairewa ki Methanol.Tino Iti Ewaro.Kore ki te Dichloromethane |
| COA & MSDS | Kei te waatea |
| Taketake | Shanghai, Haina |
| Waitohu | Ruifu Chemical |
| Nga taonga | Whakatakotoranga | Hua |
| Te ahua | Ma ki te Paura-White | Paura ma |
| Whakamātautau (na HPLC) | 98.0~102.0% | 99.34% |
| Wai na Karl Fischer | 4.5~6.5% | Ka tutuki |
| Te toenga i runga i te mura | ≤0.10% | <0.10% |
| Konga Taamaha (Pb) | ≤10ppm | <10ppm |
| Pramipexole propionamidea | ≤0.15% | Ka tutuki |
| Pramipexole Related Compound A | ≤0.15% | Ka tutuki |
| N-Propylpramipexole | ≤0.15% | Ka tutuki |
| Pramipexole Dimer | ≤0.15% | Ka tutuki |
| Tetahi atu poke o te tangata takitahi | ≤0.10% | Ka tutuki |
| Enantiomeric Purity | ≤1.00% | Ka tutuki |
| Pararaiha | ≤5ppm | <5ppm |
| Spectrum Infrared | E rite ana ki te Hanganga | Ka tutuki |
| 1H NMR Spectrum | E rite ana ki te Hanganga | Ka tutuki |
| Whakamutunga | Kua whakamatauria te hua me te whai ki nga whakaritenga kua tohua | |
Mōkī:Pounamu Fluorinated, Peeke pepa konumohe, 25kg / Cardboard Drum, kia rite ranei ki te hiahia a te kaihoko.
Tikanga Rokiroki:Kia kati te ipu ka penapena ki roto i te whare putunga hauhautanga, maroke (2~8 ℃) me te hau pai kia matara atu i nga matū hotokore.Tiaki i te marama me te makuku.
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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].
WHAKAMAHI
Kei roto i te Pramipexole Dihydrochloride te NLT 98.0% me te NMT 102.0% o te C10H19Cl2N3S, kua tatauhia i runga i te kaupapa anhydrous.
WHAKATAUTANGA
• A. Te Kohanga Pokarekare <197A> ranei <197M>
Awhe tau ngaru: <197A>, 3800 cm-1 ki te 650 cm-1;<197M>, 4000 cm-1 ki te 600 cm-1
• B. Ko te wa pupuri o te tihi nui i roto i te otinga Tauira e rite ana ki tera o te pramipexole (S-enantiomer) i roto i te otinga pai o te punaha i roto i te whakamatautau mo te Enantiomeric Purity.
• C. Whakamātautau Tautuhinga-General, Chloride <191>
Tauira: 1 mg/mL o Pramipexole Dihydrochloride i roto i te wai
Paearu Whakaaetanga: Ka tutuki nga whakaritenga o te whakamatautau parawai parakawa hiriwa
WHAKAMAHI
• Tikanga
Otinga A: Whakarewahia te 9.1 g o te pāhare pāporo dihydrogen phosphate me te 5.0 g o te konutai 1-octanesulfonate monohydrate ki te 1 L o te wai.Whakaritea me te waikawa phosphoric ki te pH 3.0.
Otinga B: Acetonitrile me Otinga A (1:1)
Diluent: Acetonitrile me Solution A (1:4)
Wāhanga pūkoro: Tirohia te ripanga rōnaki i raro nei.
Wā (meneti) Rongoā A (%) Rongoā B (%)
0 60 40
15 20 80
15.1 60 40
20 60 40
Te otinga pai o te punaha: 1.5 mg/mL o USP Pramipexole Dihydrochloride RS me te 0.8 mg/mL o USP Pramipexole Related Compound A RS i te Diluent
Wairewa Paerewa: 1.5 mg/mL o USP Pramipexole Dihydrochloride RS i roto i te Diluent
Tauira otinga: 1.5 mg/mL o Pramipexole Dihydrochloride i te Diluent
Pūnaha Chromatographic
(Tirohia te Chromatography <621>, Whakaritenga Pūnaha.)
Aratau: LC
Kaitirotiro: UV 264 nm
Tīwae: 4.6-mm × 15-cm;5-µm tākai L1
Paemahana tīwae: 40 ± 5
Rere rere: 1.5 mL/min
Rahi werohanga: 5 µL
Te pai o te punaha
Tauira: Te otinga pai o te punaha me te otinga Paerewa [Tuhipoka-Ko nga wa e pupuri ana mo te puhui A me te pramipexole e pa ana ki te 0.7 me te 1.0.]
Nga whakaritenga e tika ana
Whakatau: NLT 6.0 i waenga i te pūhui A me te pramipexole, te otinga pai o te punaha
Te take hiku: NMT 2.0 mo te pramipexole, Te otinga pai o te punaha
Te inenga paerewa whaitake: NMT 1.0%, otinga Paerewa
Tātaritanga
Tauira: otinga Paerewa me te otinga Tauira
Tātaihia te ōrau o C10H19Cl2N3S i te wahanga o Pramipexole Dihydrochloride i tangohia:
Hua = (rU/rS) × (CS/CU) × (Mr1/Mr2) × 100
rU = te whakautu teitei mai i te Tauira otinga
rS = te whakautu teitei mai i te otinga Paerewa
CS = te kukū o te USP Pramipexole Dihydrochloride RS i te otinga Paerewa (mg/mL)
CU = te kukū o te otinga Tauira (mg/mL)
Mr1 = te taumaha ngota o te pramipexole dihydrochloride, 284.26
Mr2 = te taumaha ngota o te pramipexole dihydrochloride monohydrate, 302.26
Paearu whakaae: 98.0%–102.0% i runga i te waikore
NGA POKE
Nga poke parakore
• Te toenga i runga i te mura <281>: NMT 0.10%
• Nga Koura Nui, Tikanga I <231>
Wairewa Paerewa: Wairewa Aratohu Paerewa, 10 ppm
Tauira otinga: Ash 2 go Pramipexole Dihydrochloride tae noa ki te whiwhi i te papatipu waro kua tata maroke.Whakamaohia te toenga, tāpirihia te 2.0 mL o te waikawa nitric me te 5 pata o te waikawa pungatara kaha, me te ata tuku kia whanake te kohu.Whakawerahia i te 500-600 kia pau katoa te waro.Whakataohia te toenga, tāpirihia te 4 mL o te waikawa pūhaumāota 6 M, ka uhia te ipu, ka keri ki runga i te pati wai kohua mo te 15 meneti.Whakaeto ki te maroke.Tāpirihia kia kotahi pata o te waikawa pūmāota me te 10 mL o te wai wera, ka keri mo te 2 meneti i runga i te pati wai kohua.Taapirihia te wairewa haukinia 6 M kia iti noa te kawakore o te wairewa, ka whakatika me te 1 M waikawa ahetiki ki te pH 3.0–4.0.Tātarihia te wairewa ki roto i te ipu rōrahi 25-mL, ka waimeha ki te wai ki te 25 mL mā te horoi i te ipu me te tātari.
Paearu whakaae: NMT 10 ppm
Nga poke pararopi
• Tikanga
Rongoā A, Rongoā B, Diluent, Waa pūkoro, me te Pūnaha Chromatographic: Haere tonu i roto i te Whakatairanga.
Te otinga pai o te punaha: 7.5 µg/mL o USP Pramipexole Dihydrochloride RS me te 3 µg/mL o USP Pramipexole Related Compound A RS i te Diluent
Wairewa Paerewa: 1.5 µg/mL o USP Pramipexole Dihydrochloride RS i roto i te Diluent
Tauira otinga: 1.5 mg/mL o Pramipexole Dihydrochloride i te Diluent
Te pai o te punaha
Tauira: Te otinga pai o te punaha me te otinga Paerewa
Nga whakaritenga e tika ana
Whakatau: NLT 6.0 i waenga i te pūhui A me te pramipexole, te otinga pai o te punaha
Te take hiku: NMT 2.0 mo te pramipexole, Te otinga pai o te punaha
Te inenga paerewa patata: NMT 5.0%, otinga Paerewa
Tātaritanga
Tauira: otinga Paerewa me te otinga Tauira
Tātaihia te ōrau o te poke takitahi i te wahanga o Pramipexole Dihydrochloride i tangohia:
Hua = (rU/rS) × (CS/CU) × (Mr1/Mr2) × 100
rU = te whakautu teitei o ia poke mai i te otinga Tauira
rS = te whakautu teitei o te pramipexole mai i te otinga Paerewa
CS = te kukū o te USP Pramipexole Dihydrochloride RS i te otinga Paerewa (mg/mL)
CU = te kukū o te pramipexole dihydrochloride monohydrate i roto i te Tauira otinga (mg/mL)
Mr1 = te taumaha ngota o te pramipexole dihydrochloride, 284.26
Mr2 = te taumaha ngota o te pramipexole dihydrochloride monohydrate, 302.26
Paearu whakaae
Nga poke takitahi: Tirohia te Ripanga poke 1.
Tapeke poke: NMT 0.5%
Ripanga poke 1
Ingoa Waa Pupuri Paanga Paearu Whakaaetanga, NMT (%)
Pramipexole propionamidea 0.5 0.15
Pramipexole pūhui pā Ab 0.7 0.15
Pramipexole 1.0 —
N-Propylpramipexolec 1.4 0.15
Pramipexole dimerd 1.7 0.15
Tetahi atu poke takitahi kaore i mohiotia - 0.10
he (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).He dimer tenei o te pramipexole (he ranunga o nga inemate e wha pea).
NGA WHAKAMATAUTANGA
• Te Whakatau Wai, Tikanga I <921>: NLT 4.5% me NMT 6.5%
• Enantiomeric Purity
Wāhanga pūkoro: n-Hexane, waipiro maroke, me te diethylamine (850:150:1)
He otinga kararehe pai o te punaha: 1 mg/mL ia USP Pramipexole Dihydrochloride RS me USP Pramipexole Related Compound D RS i roto i te waipiro maroke.
Te otinga pai o te punaha: 0.01 mg/mL ia USP Pramipexole Dihydrochloride RS me te USP Pramipexole Related Compound D RS mai i te otinga kararehe pai o te punaha i roto i te waahanga Waahanga
Te otinga kararehe paerewa: 2.0 mg/mL o USP Pramipexole Related Compound D RS i roto i te waipiro maroke
Wairewa Paerewa: 1.5 µg/mL o te USP Pramipexole Pānga Pūhui D RS i roto i te wahanga Pūkoro
Tauira otinga: 0.3 mg/mL, he mea whakarite ma te whakakore i te rahinga tika o te Pramipexole Dihydrochloride kua paunatia ki te 25% o te rōrahi ipu o te waipiro maroke me te waimeha ki te wahanga Waea pūkoro ki te rōrahi
Pūnaha Chromatographic
(Tirohia Chromatography 621, Pūnaha Whakaritenga.)
Aratau: LC
Kaitirotiro: UV 254 nm
Tīwae: 4.6-mm × 25-cm;10-µm tākai L51
Rere rere: 1.5 mL/min
Rahi tauira: 75 µL
Te pai o te punaha
Tauira: Te otinga pai o te punaha [Tuhipoka-Ko nga wa pupuri whanaunga mo te puhui e pa ana ki te pramipexole D (R-enantiomer) me te pramipexole (S-enantiomer) he 0.5 me te 1.0.]
Nga whakaritenga e tika ana
Whakatau: NLT 5.0 i waenga i te pūhui D me te pramipexole, te otinga pai o te punaha
Te take hiku: NMT 2.4 mo te pramipexole, Te otinga pai o te punaha
Tātaritanga
Tauira: otinga Paerewa me te otinga Tauira
Tātaihia te ōrau o te pūhui e pā ana ki te pramipexole D i te wahanga o te Pramipexole Dihydrochloride i tangohia:
Hua = (rU/rS) × (CS/CU) × 100
rU = te whakautu teitei o te puhui hono D pramipexole mai i te otinga Tauira
rS = te whakautu teitei o te puhui e pa ana ki te pramipexole D mai i te otinga Paerewa
CS = te kukū o te pūhui e pā ana ki te pramipexole D i te otinga Paerewa (mg/mL)
CU = te kukū o te otinga Tauira (mg/mL)
Paearu whakaae: NMT 1.0% o te pūhui e pā ana ki te pramipexole D
• Tepe o te Palladium
[Tuhipoka-Mahia tenei whakamatautau mena he poke pararopi e mohiotia ana te palladium.]
Diluent: 0.1 M waikawa pūmāota
Wairewa Paerewa: 40 µg/L o te palladium i roto i te Diluent, mai i te otinga paerewa palladium e hokona ana mo te whakauru ngota/te plasma hono inductively.[Tuhipoka—Whakaritea houtia tenei otinga ina hiahiatia i te ra whakamahi.]
Tauira otinga: Ki te 0.5 kara o te Pramipexole Dihydrochloride i roto i te ipu 50-mL ka taapirihia te 5.00 mL o te 1 M waikawa puota, ka memeha me te whakamahana.Matao ki te pāmahana rūma, me te waimeha ki te wai ki te rōrahi.
Ngā tikanga tūāpapa
(Tirohia te Spectrophotometry and Light-Scattering 851).
Aratau: Spectrophotometry ngota ngota
Te roangaru wetewete: Raina tukunga Palladium i te 247.6 nm
Rama: Cathode Hollow
Pūtake ngota: Umu kauwhata.[Tuhipoka—Whaia te raupapatanga whakahoahoa a te kaihanga.]
Rahi tauira: 20 µL
Patea: Diluent
Te pai o te punaha
Tauira: otinga Paerewa
Nga whakaritenga e tika ana
Rorohanga: NLT 0.034
Tātaritanga
Tauira: otinga Paerewa me te otinga Tauira
Whakatauhia te kukū o te palladium i roto i te Tauira otinga ma te tikanga taapiri paerewa.
Paearu whakaae: NMT 5 ppm
HE WHAKAMAHI ATU
• Te Whakapai me te Rokiroki: Whakaorangia i roto i nga ipu kua kati pai, ka tiakina mai i te makuku me te marama.
• Paerewa Tohutoro USP 11
USP Pramipexole Dihydrochloride RS Pāwhiri ki te Tiro Hanganga
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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Ka whakamahia te Pramipexole Dihydrochloride Monohydrate (CAS: 191217-81-9)
