Pramipexole Dihydrochloride Monohydrate CAS 191217-81-9 Assay 98.0~102.0%
Ruifu Chemical minangka produsen terkemuka Pramipexole Dihydrochloride Monohydrate (CAS: 191217-81-9) kanthi kualitas dhuwur.Ruifu Chemical bisa nyedhiyakake pangiriman ing saindenging jagad, rega sing kompetitif, layanan sing apik, jumlah cilik lan akeh sing kasedhiya.Tuku Pramipexole Dihydrochloride Monohydrate,Please contact: alvin@ruifuchem.com
| Jeneng Kimia | Pramipexole Dihydrochloride Monohydrate |
| sinonim | Pramipexole DiHCL Monohydrate;Pramipexole 2HCl Monohydrate;(S)-2-Amino-4,5,6,7-Tetrahydro-6-(Propylamino)benzothiazole Dihydrochloride Monohydrate |
| Status Simpenan | Ing Saham, Produksi Komersial |
| Nomer CAS | 191217-81-9 |
| CAS sing gegandhengan | 104632-25-9 & 104632-26-0 |
| Formula Molekul | C10H17N3S·2HCl·H2O |
| Bobot Molekul | 302,26 g / mol |
| Titik Lebur | 290 ℃ (des.) |
| Rotasi Spesifik [a]20/D | -65,0° nganti -71,0° (C=1 ing MeOH)(calcd.on anh.substance) |
| Kelarutan banyu | Larut ing banyu |
| Kelarutan | Larut ing Metanol.Etanol Rada Banget.Ora larut ing Dichloromethane |
| COA & MSDS | kasedhiya |
| asale | Shanghai, China |
| Merk | Kimia Ruifu |
| barang | Spesifikasi | Asil |
| Penampilan | Bubuk Putih nganti Putih | Bubuk Putih |
| Assay (dening HPLC) | 98.0~102.0% | 99,34% |
| Banyu dening Karl Fischer | 4,5 nganti 6,5% | tundhuk |
| Sisa ing Ignition | ≤0,10% | <0,10% |
| Logam Berat (Pb) | ≤10ppm | <10 ppm |
| Pramipexole propionamidea | ≤0,15% | tundhuk |
| Senyawa sing gegandhengan karo Pramipexole A | ≤0,15% | tundhuk |
| N-Propylpramipexole | ≤0,15% | tundhuk |
| Pramipexole Dimer | ≤0,15% | tundhuk |
| Sembarang Kotoran Individu sing Ora dingerteni Liyane | ≤0,10% | tundhuk |
| Kemurnian enantiomer | ≤1,00% | tundhuk |
| Palladium | ≤5ppm | <5 ppm |
| Spektrum Infrared | Konsisten karo Struktur | tundhuk |
| Spektrum 1H NMR | Konsisten karo Struktur | tundhuk |
| Kesimpulan | Produk wis diuji lan tundhuk karo spesifikasi sing diwenehake | |
Paket:Botol Fluorinated, tas Aluminium foil, 25kg / Drum Karton, utawa miturut kabutuhan pelanggan.
Kondisi panyimpenan:Tansah wadhah ditutup kanthi rapet lan simpen ing gudang sing adhem, garing (2 ~ 8 ℃) lan kanthi ventilasi sing adoh saka bahan sing ora cocog.Nglindhungi saka cahya lan Kelembapan.
Pengiriman:Ngirim menyang donya liwat udhara, dening FedEx / DHL Express.Nyedhiyakake pangiriman sing cepet lan dipercaya.
C10H17N3S·2HCl·H2O 302.26
(S)-2-Amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate [191217-81-9].
DEFINISI
Pramipexole Dihydrochloride ngandhut NLT 98,0% lan NMT 102,0% saka C10H19Cl2N3S, diwilang ing basis anhydrous.
IDENTIFIKASI
• A. Penyerapan Infra Merah <197A> utawa <197M>
Rentang nomer gelombang: <197A>, 3800 cm-1 nganti 650 cm-1;<197M>, 4000 cm-1 kanggo 600 cm-1
• B. Wektu penylametan puncak utama ing solusi Sample cocog karo pramipexole (S-enantiomer) ing solusi kesesuaian Sistem ing test kanggo Enantiomeric Purity.
• C. Tes Identifikasi-Umum, Klorida <191>
Sampel: 1 mg/mL Pramipexole Dihydrochloride ing banyu
Kritéria panrima: Nyukupi syarat tes endapan perak nitrat
ASSAY
• Tata cara
Solusi A: Larutake 9,1 g kalium dihidrogen fosfat lan 5,0 g sodium 1-octanesulfonate monohydrate ing 1 L banyu.Setel karo asam fosfat nganti pH 3,0.
Solusi B: Acetonitril lan Solusi A (1: 1)
Diluent: Acetonitril lan Solusi A (1: 4)
Fase seluler: Deleng tabel gradien ing ngisor iki.
Wektu (min) Solusi A (%) Solusi B (%)
0 60 40
15 20 80
15.1 60 40
20 60 40
Solusi kesesuaian sistem: 1,5 mg/mL USP Pramipexole Dihydrochloride RS lan 0,8 mg/mL USP Pramipexole Related Compound A RS ing Diluent
Solusi standar: 1,5 mg/mL USP Pramipexole Dihydrochloride RS ing Diluent
Solusi sampel: 1,5 mg/mL Pramipexole Dihydrochloride ing Diluent
Sistem kromatografi
(Deleng Kromatografi <621>, Kesesuaian Sistem.)
Mode: LC
Detektor: UV 264 nm
Kolom: 4,6-mm × 15-cm;5-µm kemasan L1
Suhu kolom: 40 ± 5
Laju aliran: 1,5 mL / min
Ukuran injeksi: 5 µL
Kesesuaian sistem
Sampel: Solusi kesesuaian sistem lan solusi Standar [Cathetan-Wektu retensi relatif kanggo senyawa A sing gegandhengan karo pramipexole lan pramipexole kira-kira 0,7 lan 1,0.]
Syarat kesesuaian
Resolusi: NLT 6.0 antarane senyawa A sing gegandhengan karo pramipexole lan pramipexole, Solusi kesesuaian sistem
Faktor Tailing: NMT 2.0 kanggo pramipexole, Solusi kesesuaian sistem
Panyimpangan standar relatif: NMT 1,0%, Solusi standar
Analisis
Sampel: Solusi standar lan solusi Sampel
Hitung persentase C10H19Cl2N3S ing porsi Pramipexole Dihydrochloride sing dijupuk:
Hasil = (rU/rS) × (CS/CU) × (Mr1/Mr2) × 100
rU = respon puncak saka solusi Sampel
rS = respon puncak saka solusi Standar
CS = konsentrasi USP Pramipexole Dihydrochloride RS ing larutan Standar (mg/mL)
CU = konsentrasi larutan sampel (mg/mL)
Mr1 = bobot molekul pramipexole dihydrochloride, 284,26
Mr2 = bobot molekul pramipexole dihydrochloride monohydrate, 302,26
Kritéria panampa: 98,0% -102,0% kanthi basis anhidrat
REGED
Kotoran anorganik
• Sisa nyala <281>: NMT 0,10%
• Logam Berat, Metode I <231>
Solusi standar: Solusi Timbal Standar, 10 ppm
Solusi sampel: Awu 2 g Pramipexole Dihydrochloride nganti massa karbonisasi sing meh garing.Kelangan ampas, tambahake 2,0 ml asam nitrat pekat lan 5 tetes asam sulfat pekat, lan kanthi ati-ati ngidini asap kasebut berkembang.Ngobong ing 500-600 nganti karbon rampung diobong.Kelangan ampas, tambahake 4 ml asam hidroklorat 6 M, nutupi crucible, lan dicerna ing adus banyu sing nggodhok nganti 15 menit.Evaporate nganti garing.Tambah siji tetes asam hidroklorat pekat lan 10 ml banyu panas, lan dicerna nganti 2 menit maneh ing adus banyu sing nggodhok.Nambahake larutan amonia 6 M kanthi tetes nganti larutan kasebut rada alkalin, lan atur nganggo asam asetat 1 M nganti pH 3,0-4,0.Nyaring solusi menyang labu volumetrik 25-mL, lan diencerke banyu nganti 25 ml kanthi ngumbah crucible lan saringan.
Kritéria panampa: NMT 10 ppm
Kotoran Organik
• Tata cara
Solusi A, Solusi B, Pengencer, Fase seluler, lan sistem Kromatografi: Terusake kaya sing diarahake ing Pengujian.
Solusi kesesuaian sistem: 7,5 µg/mL USP Pramipexole Dihydrochloride RS lan 3 µg/mL USP Pramipexole Related Compound A RS ing Diluent
Solusi standar: 1,5 µg/mL USP Pramipexole Dihydrochloride RS ing Diluent
Solusi sampel: 1,5 mg/mL Pramipexole Dihydrochloride ing Diluent
Kesesuaian sistem
Sampel: Solusi kesesuaian sistem lan solusi Standar
Syarat kesesuaian
Resolusi: NLT 6.0 antarane senyawa A sing gegandhengan karo pramipexole lan pramipexole, Solusi kesesuaian sistem
Faktor Tailing: NMT 2.0 kanggo pramipexole, Solusi kesesuaian sistem
Panyimpangan standar relatif: NMT 5,0%, Solusi standar
Analisis
Sampel: Solusi standar lan solusi Sampel
Hitung persentasi saka sembarang najis individu ing bagean saka Pramipexole Dihydrochloride dijupuk:
Hasil = (rU/rS) × (CS/CU) × (Mr1/Mr2) × 100
rU = respon puncak saben impurity saka solusi Sampel
rS = respon puncak pramipexole saka solusi Standar
CS = konsentrasi USP Pramipexole Dihydrochloride RS ing larutan Standar (mg/mL)
CU = konsentrasi pramipexole dihydrochloride monohydrate ing larutan Sampel (mg/mL)
Mr1 = bobot molekul pramipexole dihydrochloride, 284,26
Mr2 = bobot molekul pramipexole dihydrochloride monohydrate, 302,26
Kritéria ditampa
Kotoran individu: Waca Tabel Kotor 1.
Total impurities: NMT 0,5%
Tabel Kotoran 1
Kriteria Penerimaan Wektu Relatif Relatif, NMT (%)
Pramipexole propionamidea 0,5 0,15
Pramipexole senyawa related Ab 0.7 0.15
Pramipexole 1.0 -
N-Propylpramipexolec 1.4 0.15
Pramipexole dimerd 1.7 0.15
Kotoran individu liyane sing ora dingerteni - 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).Iki minangka dimer saka pramipexole (campuran saka papat isomer sing mungkin).
TES KHUSUS
• Penentuan Banyu, Metode I <921>: NLT 4,5% lan NMT 6,5%
• Enantiomeric Purity
Fase gerak: n-Heksan, alkohol dehidrasi, lan dietilamin (850:150:1)
Solusi stok kesesuaian sistem: 1 mg/mL saben USP Pramipexole Dihydrochloride RS lan USP Pramipexole Related Compound D RS ing alkohol dehidrasi
Solusi kesesuaian sistem: 0,01 mg/mL saben USP Pramipexole Dihydrochloride RS lan USP Pramipexole Related Compound D RS saka solusi stok kesesuaian sistem ing fase Mobile
Solusi stok standar: 2,0 mg/mL saka USP Pramipexole Related Compound D RS ing alkohol dehidrasi
Solusi standar: 1,5 µg/mL USP Pramipexole Related Compound D RS in Mobile phase
Solusi sampel: 0,3 mg/mL, disiapake kanthi larutake Pramipexole Dihydrochloride jumlahe sing cocog ing 25% saka volume labu alkohol dehidrasi lan diencerake nganggo fase gerak nganti volume.
Sistem kromatografi
(Deleng Kromatografi 621, Kesesuaian Sistem.)
Mode: LC
Detektor: UV 254 nm
Kolom: 4,6-mm × 25-cm;10-µm packing L51
Laju aliran: 1,5 mL / min
Ukuran sampel: 75 µL
Kesesuaian sistem
Sampel: Solusi kesesuaian sistem [Cathetan-Kaping retensi relatif kanggo senyawa sing gegandhengan karo pramipexol D (R-enantiomer) lan pramipexole (S-enantiomer) yaiku 0,5 lan 1,0.]
Syarat kesesuaian
Resolusi: NLT 5.0 antarane pramipexole related senyawa D lan pramipexole, System suitability solution
Faktor tailing: NMT 2.4 kanggo pramipexole, Solusi kesesuaian sistem
Analisis
Sampel: Solusi standar lan solusi Sampel
Hitung persentase senyawa sing ana gandhengane karo pramipexol D ing bagean Pramipexole Dihydrochloride sing dijupuk:
Asil = (rU/rS) × (CS/CU) × 100
rU = respon puncak senyawa pramipexole related D saka solusi Sampel
rS = respon puncak senyawa pramipexole related D saka solusi Standar
CS = konsentrasi senyawa pramipexole D ing larutan Standar (mg/mL)
CU = konsentrasi larutan sampel (mg/mL)
Kriteria panampa: NMT 1,0% senyawa sing ana gandhengane karo pramipexole D
• Watesan saka Palladium
[Cathetan-Nindakake tes iki yen palladium minangka najis anorganik sing dikenal.]
Diluent: 0,1 M asam klorida
Solusi standar: 40 µg/L paladium ing Diluent, saka solusi standar paladium sing kasedhiya kanthi komersial kanggo panyerepan atom/plasma gabungan induktif.[Cathetan-Siapkan solusi iki kaya sing dibutuhake ing dina panggunaan.]
Solusi sampel: Kanggo 0,5 g Pramipexole Dihydrochloride ing labu volumetrik 50-mL nambah 5,00 mL asam hidroklorat 1 M, lan larut kanthi pemanasan.Kelangan nganti suhu kamar, lan dilute banyu nganti volume.
Kondisi spektrometri
(Deleng Spektrofotometri lan Panyebaran Cahya 851).
Mode: Spektrofotometri serapan atom
Dawane gelombang analitik: Garis emisi Palladium ing 247,6 nm
Lampu: katoda berongga
Sumber atomisasi: tungku grafit.[Cathetan—Tindakake urutan pemrograman sing disaranake pabrikan.]
Ukuran sampel: 20 µL
Blank: Diluent
Kesesuaian sistem
Sampel: Solusi standar
Syarat kesesuaian
Penyerapan: NLT 0,034
Analisis
Sampel: Solusi standar lan solusi Sampel
Nemtokake konsentrasi paladium ing larutan Sampel kanthi metode tambahan standar.
Kritéria panampa: NMT 5 ppm
SYARAT TAMBAHAN
• Kemasan lan Panyimpenan: Simpen ing wadhah sing ditutup kanthi apik, dilindhungi saka kelembapan lan cahya.
• Standar Referensi USP 11
USP Pramipexole Dihydrochloride RS Klik kanggo Ndeleng Struktur
USP Pramipexole Related Compound A RS
(S)-4,5,6,7-Tetrahydrobenzothiazole-2,6-diamine.
C7H11N3S 169.25
USP Pramipexole Related Senyawa 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) digunakake
