Vildagliptin
Vildagliptin CAS: 274901-16-5
Properti Kimia Vildagliptin
MF: C17H25N3O2
MW: 303.4
Titik lebur: 153-155C
Titik didih: 531.3 ± 50.0 ° C (Ramalan)
Kapadhetan: 1.27
Fp: 275.1â „ƒ
Spesifikasi Vildagliptin:
|
Barang |
Standar |
Asil analisis |
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Penampilan |
Wêdakakêna kristal putih |
Wêdakakêna kristal putih |
|
Kelarutan
|
Gampang larut ing metanol, etanol, dimetil suloksida, banyu utawa larutan asam hidroklorat 0,01 mol / L, rada larut ing asetonitril utawa isopropanol. |
Selaras |
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Identifikasi |
Mirip karo retensi standar HPLC. |
Selaras |
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Identik karo spesialisasi IR standar. |
Selaras |
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|
Banyu |
â ‰ ¤1,0% |
0,21% |
|
Titik lebur |
148â „ƒ-152â„ ƒ |
149.3-151.4â „ƒ |
|
Sisa ing kontak |
â ‰ ¤0,1% |
0,03% |
|
Logam abot |
â ‰ ¤20ppm |
＜20ppm |
|
Sulfat |
â ‰ ¤0.02% |
Selaras |
|
Klorida |
Selaras |
|
|
Kotor impor |
R-isomer impurityâ ¤0.5% |
0,01% |
|
Pelarut sisa |
Etanolâ ‰ 0005000ppm |
318ppm |
|
Acetoneâ ‰ ¤5000ppm |
33ppm |
|
|
Acetonitrileâ ‰ 10410ppm |
ND |
|
|
Butil asetatâ ‰ 0005000ppm |
ND |
|
|
DMFâ ‰ ¤880ppm |
ND |
|
|
Etil asetatâ ‰ 0005000ppm |
ND |
|
|
Methanolâ ‰ ¤3000ppm |
ND |
|
|
Methylene Klorida≤600ppm |
ND |
|
|
Methyl etil ketoneâ ‰ 0005000ppm |
ND |
|
|
Tolueneâ ‰ ¤890ppm |
ND |
|
|
Alkohol Isopropilâ ‰ 0005000ppm |
ND |
|
|
Gegandhengan impurity (HPLC) |
Impurity Bâ ¤0.15% |
ND |
|
Impurity Câ ‰0,2% |
0,08% |
|
|
Individual impurityâ ‰ ¤0,1% |
0,04% |
|
|
Total impuritiesâ ‰ ¤1,0% |
0,17% |
|
|
Gegandhengan impurity （GCï¼ ‰ |
Impurity A ‰ ¤0,15% |
ND |
|
Asil HPLC |
98,0%% 10,0% |
99,6% |
|
Ukuran partikel |
D90â ‰ ¤150μ |
D90＜100μ |
|
Kesimpulan |
Selarass withEnterprisestandard. |
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