Pramipexole Dihydrochloride Monohydrate CAS 191217-81-9 Assay 98.0 ~ 102.0%
Ruifu Chemical shine jagoran masana'anta na Pramipexole Dihydrochloride Monohydrate (CAS: 191217-81-9) tare da inganci.Ruifu Chemical na iya samar da isar da saƙo na duniya, farashi mai gasa, kyakkyawan sabis, ƙanana da adadi mai yawa akwai.Sayi Pramipexole Dihydrochloride Monohydrate,Please contact: alvin@ruifuchem.com
| Sunan Sinadari | Pramipexole Dihydrochloride Monohydrate |
| Makamantu | Pramipexole DiHCL Monohydrate;Pramipexole 2HCl Monohydrate;(S)-2-Amino-4,5,6,7-Tetrahydro-6-(Propylamino)benzothiazole Dihydrochloride Monohydrate |
| Matsayin Hannun jari | A Stock, Kasuwancin Kasuwanci |
| Lambar CAS | 191217-81-9 |
| CAS mai alaƙa | 104632-25-9 & 104632-26-0 |
| Tsarin kwayoyin halitta | C10H17N3S·2HCl·H2O |
| Nauyin Kwayoyin Halitta | 302.26 g/mol |
| Matsayin narkewa | 290 ℃ (Dec.) |
| Takamaiman Juyawa [a] 20/D | -65.0° zuwa -71.0° (C=1 a cikin MeOH)(calcd.on anh.substance) |
| Ruwan Solubility | Mai narkewa a cikin Ruwa |
| Solubility | Mai narkewa a cikin methanol.Ethanol kadan sosai.Insoluble a cikin Dichloromethane |
| COA & MSDS | Akwai |
| Asalin | Shanghai, China |
| Alamar | Ruifu Chemical |
| Abubuwa | Ƙayyadaddun bayanai | Sakamako |
| Bayyanar | Fari zuwa Kashe-Farin Foda | Farin Foda |
| Assay (ta HPLC) | 98.0 ~ 102.0% | 99.34% |
| Ruwa ta Karl Fischer | 4.5 ~ 6.5% | Ya bi |
| Ragowa akan Ignition | ≤0.10% | <0.10% |
| Karfe masu nauyi (Pb) | ≤10ppm | <10ppm |
| Pramipexole Propionamidea | ≤0.15% | Ya bi |
| Abubuwan da ke da alaƙa da Pramipexole A | ≤0.15% | Ya bi |
| N-Propylpramipexole | ≤0.15% | Ya bi |
| Pramipexole Dimer | ≤0.15% | Ya bi |
| Duk Wani Rashin Tsaftar Mutum Ba A Gane Ba | ≤0.10% | Ya bi |
| Enantiomeric Tsabta | ≤1.00% | Ya bi |
| Palladium | ≤5pm | <5ppm |
| Infrared Spectrum | Daidai da Tsarin | Ya bi |
| 1H NMR Spectrum | Daidai da Tsarin | Ya bi |
| Kammalawa | An gwada samfurin kuma ya dace da ƙayyadaddun da aka bayar | |
Kunshin:Fluorinated Bottle, Aluminum tsare jakar, 25kg / Kwali Drum, ko bisa ga abokin ciniki ta bukata.
Yanayin Ajiya:Ajiye akwati sosai kuma a adana a wuri mai sanyi, bushe (2 ~ 8 ℃) da ma'ajin da ke da isasshen iska daga abubuwan da ba su dace ba.Kare daga haske da danshi.
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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].
BAYANI
Pramipexole Dihydrochloride ya ƙunshi NLT 98.0% da NMT 102.0% na C10H19Cl2N3S, ƙididdigewa akan tushen anhydrous.
GANO
• A. Ciwon Infrared <197A> ko <197M>
Kewayon lambar igiyar ruwa: <197A>, 3800 cm-1 zuwa 650 cm-1;<197M>, 4000 cm-1 zuwa 600 cm-1
• B. Lokacin riƙewa na babban kololuwa a cikin Samfurin bayani yayi daidai da na pramipexole (S-enantiomer) a cikin tsarin dacewa da tsarin a cikin gwajin Enantiomeric Purity.
• C. Gwajin Gano-Gaba ɗaya, Chloride <191>
Misali: 1 mg/mL na Pramipexole Dihydrochloride a cikin ruwa
Sharuɗɗan karɓa: Ya cika buƙatun gwajin nitrate na azurfa
ASSAY
• Tsari
Magani A: Narke 9.1 g na potassium dihydrogen phosphate da 5.0 g na sodium 1-octanesulfonate monohydrate a cikin 1 L na ruwa.Daidaita tare da phosphoric acid zuwa pH na 3.0.
Magani B: Acetonitrile da Magani A (1:1)
Diluent: Acetonitrile da Magani A (1:4)
Matakin wayar hannu: Duba teburin gradient da ke ƙasa.
Lokaci (min) Magani A (%) Magani B (%)
060 40
15 2080
15.1 60 40
20 60 40
Maganin dacewa da tsarin: 1.5 mg/mL na USP Pramipexole Dihydrochloride RS da 0.8 mg/mL na USP Pramipexole Compound A RS a cikin Diluent
Daidaitaccen bayani: 1.5 mg/mL na USP Pramipexole Dihydrochloride RS a cikin Diluent
Maganin samfurin: 1.5 mg/mL na Pramipexole Dihydrochloride a cikin Diluent
Tsarin chromatographic
(Duba Chromatography <621>, Dacewar Tsarin.)
Yanayin: LC
Mai ganowa: UV 264 nm
Tushen: 4.6-mm × 15-cm;5-µm shiryarwa L1
Yanayin zafin jiki: 40 ± 5
Yawan gudu: 1.5 ml/min
Girman allura: 5µL
Dacewar tsarin
Samfura: Maganin dacewa da tsarin da daidaitaccen bayani [Lura-Lokacin riƙe dangi na fili mai alaƙa da pramipexole A da pramipexole kusan 0.7 da 1.0 ne, bi da bi.]
Abubuwan da suka dace
Resolution: NLT 6.0 tsakanin pramipexole da alaka fili A da pramipexole, Tsarin dacewa bayani
Matsayin wutsiya: NMT 2.0 don pramipexole, Maganin dacewa da tsarin
Matsakaicin daidaitaccen dangi: NMT 1.0%, Daidaitaccen bayani
Bincike
Samfurori: Daidaitaccen bayani da Samfurin bayani
Yi lissafin adadin C10H19Cl2N3S a cikin ɓangaren Pramipexole Dihydrochloride da aka ɗauka:
Sakamako = (rU/rS) × (CS/CU) × (Mr1/Mr2) × 100
rU = kololuwar amsa daga Maganin Samfurin
rS = kololuwar amsa daga daidaitaccen bayani
CS = maida hankali na USP Pramipexole Dihydrochloride RS a cikin daidaitaccen bayani (mg/mL)
CU = maida hankali na Maganin Samfurin (mg/mL)
Mr1 = nauyin kwayoyin pramipexole dihydrochloride, 284.26
Mr2 = nauyin kwayoyin pramipexole dihydrochloride monohydrate, 302.26
Sharuɗɗan karɓa: 98.0% -102.0% akan tushen anhydrous
RASHIN ZUCIYA
Najasa Na Inorganic
• Ragowa akan ƙonewa <281>: NMT 0.10%
• Karfe masu nauyi, Hanyar I <231>
Daidaitaccen Magani: Daidaitaccen Maganin Gubar, 10 ppm
Maganin samfurin: Ash 2 g na Pramipexole Dihydrochloride har sai an sami kusan bushewa, an sami adadin carbonized.A kwantar da ragowar, ƙara 2.0 ml na nitric acid mai mayar da hankali da 5 digo na sulfuric acid mai da hankali, kuma a hankali ƙyale tururi ya tashi.Yi wuta a 500-600 har sai carbon ya ƙone gaba daya.A kwantar da ragowar, ƙara 4 ml na 6M hydrochloric acid, rufe crucible, da kuma niƙa a kan wani ruwan zãfi na 15 min.Haɓaka zuwa bushewa.Ƙara digo ɗaya na hydrochloric acid da 10 ml na ruwan zafi, sa'annan a niƙa don ƙarin 2 min akan ruwan wanka mai tafasa.Ƙara 6M maganin ammonia a hankali har sai maganin ya kasance mai rauni alkaline, kuma daidaita tare da 1 M acetic acid zuwa pH na 3.0-4.0.Tace maganin a cikin filaye mai girma na 25-mL, kuma a tsoma shi da ruwa zuwa 25 ml ta hanyar wanke crucible da tacewa.
Sharuɗɗan karɓa: NMT 10 ppm
Najasa Na Halitta
• Tsari
Magani A, Magani B, Diluent, Wayar hannu, da tsarin Chromatographic: Ci gaba kamar yadda aka umurce a cikin Assay.
Maganin dacewa da tsarin: 7.5 µg/ml na USP Pramipexole Dihydrochloride RS da 3 μg/mL na USP Pramipexole Compound A RS a cikin Diluent
Daidaitaccen bayani: 1.5 µg/ml na USP Pramipexole Dihydrochloride RS a cikin Diluent
Maganin samfurin: 1.5 mg/mL na Pramipexole Dihydrochloride a cikin Diluent
Dacewar tsarin
Samfurori: Maganin dacewa da tsarin da daidaitaccen bayani
Abubuwan da suka dace
Resolution: NLT 6.0 tsakanin pramipexole da alaka fili A da pramipexole, Tsarin dacewa bayani
Matsayin wutsiya: NMT 2.0 don pramipexole, Maganin dacewa da tsarin
Matsakaicin daidaitaccen dangi: NMT 5.0%, Daidaitaccen bayani
Bincike
Samfurori: Daidaitaccen bayani da Samfurin bayani
Ƙirƙirar adadin kowane ƙazanta ɗaya a cikin ɓangaren Pramipexole Dihydrochloride da aka ɗauka:
Sakamako = (rU/rS) × (CS/CU) × (Mr1/Mr2) × 100
rU = kololuwar martani na kowane kazanta daga Maganin Samfurin
rS = kololuwar martani na pramipexole daga daidaitaccen bayani
CS = maida hankali na USP Pramipexole Dihydrochloride RS a cikin daidaitaccen bayani (mg/mL)
CU = maida hankali na pramipexole dihydrochloride monohydrate a cikin Sample bayani (mg/mL)
Mr1 = nauyin kwayoyin pramipexole dihydrochloride, 284.26
Mr2 = nauyin kwayoyin pramipexole dihydrochloride monohydrate, 302.26
Sharuɗɗan karɓa
Najasa ɗaya: Dubi Shafukan Najasa 1.
Jimlar ƙazanta: NMT 0.5%
Tebur Najasa 1
Sunan Sharuɗɗan Karɓar Lokaci na Dangi, NMT (%)
Pramipexole propionamidea 0.5 0.15
Abubuwan da ke da alaƙa da Pramipexole Ab 0.7 0.15
Pramipexole 1.0 -
N-Propylpramipexolec 1.4 0.15
Pramipexole dimerd 1.7 0.15
Duk wani ƙazanta na mutum da ba a bayyana ba - 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).Wannan dimer ne na pramipexole (cakuda na isomers huɗu masu yiwuwa).
MAKAMMAN JARRABAWA
• Ƙaddamar da Ruwa, Hanyar I <921>: NLT 4.5% da NMT 6.5%
• Enantiomeric Tsabta
Lokaci na wayar hannu: n-Hexane, barasa mai bushewa, da diethylamine (850:150:1)
Maganin dacewa da tsarin da ya dace: 1 mg/mL kowanne na USP Pramipexole Dihydrochloride RS da USP Pramipexole Compound D RS a cikin barasa maras ruwa.
Maganin dacewa da tsarin: 0.01 mg/mL kowanne na USP Pramipexole Dihydrochloride RS da USP Pramipexole Compound D RS daga tsarin dacewa da hannun jari a lokacin Wayar hannu
Daidaitaccen bayani na haja: 2.0 mg/mL na USP Pramipexole Mai Haɗin Haɗin D RS a cikin barasa maras ruwa
Daidaitaccen bayani: 1.5 µg/ml na USP Pramipexole Compound Compound D RS a cikin lokacin Wayar hannu
Maganin samfurin: 0.3 mg/mL, an shirya ta hanyar narkar da ma'auni mai dacewa na Pramipexole Dihydrochloride a cikin 25% na ƙarar flask na barasa mai bushewa da diluting tare da Wayar hannu zuwa girma
Tsarin chromatographic
(Duba Chromatography 621, Dacewar Tsarin.)
Yanayin: LC
Mai ganowa: UV 254 nm
Tushen: 4.6-mm × 25-cm;10-µm shiryarwa L51
Yawan gudu: 1.5 ml/min
Girman samfurin: 75 µL
Dacewar tsarin
Samfurori: Maganin dacewa da tsarin [Lura-Lokacin riƙe dangi don abubuwan da suka shafi pramipexole D (R-enantiomer) da pramipexole (S-enantiomer) sune 0.5 da 1.0, bi da bi.]
Abubuwan da suka dace
Resolution: NLT 5.0 tsakanin pramipexole mai alaka fili D da pramipexole, Tsarin dacewa da tsarin
Matsayin wutsiya: NMT 2.4 don pramipexole, Maganin dacewa da tsarin
Bincike
Samfurori: Daidaitaccen bayani da Samfurin bayani
Yi ƙididdige adadin abubuwan da ke da alaƙa da pramipexole D a cikin ɓangaren Pramipexole Dihydrochloride da aka ɗauka:
Sakamako = (rU/rS) × (CS/CU) × 100
rU = kololuwar martani na fili mai alaƙa da pramipexole D daga Maganin Samfurin
rS = kololuwar martani na fili mai alaƙa da pramipexole D daga daidaitaccen bayani
CS = maida hankali na fili mai alaƙa da pramipexole D a cikin daidaitaccen bayani (mg/mL)
CU = maida hankali na Maganin Samfurin (mg/mL)
Sharuɗɗan karɓa: NMT 1.0% na fili mai alaƙa da pramipexole D
• Iyakar Palladium
[Lura-Yi wannan gwajin idan palladium sanannen ƙazanta ne.]
Diluent: 0.1M hydrochloric acid
Daidaitaccen Magani: 40 µg/L na palladium a cikin Diluent, daga samfurin palladium na kasuwanci da ake samu don shayar atomic/haɗe-haɗe da plasma.[Lura — Shirya wannan maganin da kyau kamar yadda ake buƙata a ranar amfani.]
Maganin samfurin: Zuwa 0.5 g na Pramipexole Dihydrochloride a cikin faifan volumetric 50-mL ƙara 5.00 ml na 1 M hydrochloric acid, kuma narke tare da dumama.Yi sanyi zuwa zafin jiki, kuma tsoma da ruwa zuwa ƙarar.
Yanayin Spectrometric
(Duba Spectrophotometry da Haske- Watsawa 851).
Yanayin: Atomic absorption spectrophotometry
Tsayin Nazari: Layin watsi da Palladium a 247.6 nm
Lamba: Hollow cathode
Tushen atomization: Tanderun wuta.[Lura-Bi tsarin tsara shirye-shirye na masana'anta.]
Girman samfurin: 20 µL
Blank: Diluent
Dacewar tsarin
Misali: Daidaitaccen bayani
Abubuwan da suka dace
Saukewa: NLT 0.034
Bincike
Samfurori: Daidaitaccen bayani da Samfurin bayani
Ƙayyade ƙididdiga na palladium a cikin Samfurin bayani ta daidaitaccen hanyar ƙari.
Sharuɗɗan karɓa: NMT 5 ppm
KARIN BUKATA
• Marufi da Ajiye: Ajiye a cikin kwantena masu kyau, an kare su daga danshi da haske.
• Matsayin Magana na USP 11
USP Pramipexole Dihydrochloride RS Danna don Duba Tsarin
Abubuwan da ke da alaƙa da USP Pramipexole A RS
(S) -4,5,6,7-Tetrahydrobenzothiazole-2,6-diamine.
C7H11N3S 169.25
Abubuwan da ke da alaƙa da USP Pramipexole D RS
(R) -2-Amino-4,5,6,7-tetrahydro-6- (propylamino) benzothiazole.
C10H17N3S 211.33
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Ana amfani da Pramipexole Dihydrochloride Monohydrate (CAS: 191217-81-9)
