Vildagliptin
Vildagliptin CAS: 274901-16-5
Sifat Kimia Vildagliptin
MF: C17H25N3O2
MW: 303.4
Takat lebur: 153-155C
Titik didih: 531.3 ± 50.0 ° C (Ramalan)
Ketumpatan: 1.27
Fp: 275.1â „ƒ
Spesifikasi Vildagliptin:
|
Barang |
Piawaian |
Hasil analisis |
|
Penampilan |
Serbuk kristal putih |
Serbuk kristal putih |
|
Keterlarutan
|
Mudah larut dalam metanol, etanol, dimetil sulfoksida, air atau larutan asid hidroklorik 0.01 mol / L, sedikit larut dalam asetonitril atau isopropanol. |
Bersesuaian |
|
Pengenalan |
Sama dengan pengekalan standard HPLC. |
Bersesuaian |
|
Sama dengan spirum IR standard. |
Bersesuaian |
|
|
Air |
â ‰1.0% |
0.21% |
|
Takat lebur |
148 â ƒ-152â „ƒ |
149.3-151.4â „ƒ |
|
Sisa pada pencucuhan |
â ‰0.1% |
0.03% |
|
Logam berat |
â ‰20ppm |
2020ppm |
|
Sulfat |
â ‰0.02% |
Bersesuaian |
|
Klorida |
Bersesuaian |
|
|
Kekotoran kiral |
Kekotoran R-isomer ‰ .50.5% |
0.01% |
|
Pelarut sisa |
Etanol ‰ 0005000 ppm |
318 ppm |
|
Acetoneâ ‰5000ppm |
33ppm |
|
|
Acetonitrile ‰ 10410 ppm |
ND |
|
|
Butil asetatâ ‰5000ppm |
ND |
|
|
DMFâ ‰880ppm |
ND |
|
|
Etil asetatâ ‰5000ppm |
ND |
|
|
Metanolâ ‰3000ppm |
ND |
|
|
Methylene Klorida≤600ppm |
ND |
|
|
Metil etil keton ‰ 0005000ppm |
ND |
|
|
Toluene ‰ 90890 ppm |
ND |
|
|
Isopropil Alkohol ‰ ¤5000ppm |
ND |
|
|
Kekotoran yang berkaitan (HPLC) |
Kekotoran Bâ ‰ .10.15% |
ND |
|
Kekotoran C ‰ .20.2% |
0,08% |
|
|
Individual impurityâ ‰0.1% |
0.04% |
|
|
Total impuritiesâ ‰1.0% |
0.17% |
|
|
Kekotoran yang berkaitan （GCï¼ ‰ |
Kekotoran A ‰ .1 0,15% |
ND |
|
Ujian HPLC |
98.0% ～102.0% |
99.6% |
|
Saiz Zarah |
D90⠉150μ |
D90＜100μ |
|
Kesimpulannya |
Bersesuaians withEnterprisestandard. |
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