170729-80-3 Aprepitant 5-{[(2R,3S)-2-{(1R)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy}-3-(4-fluorophenyl)morpholin-4-yl]methyl}-1,2-dihydro-3H-1,2,4-triazol-3-one
Name |
Aprepitant |
CAS No | 170729-80-3 |
MF | C23H21F7N4O3 |
Purity | 99% |
Appearance | white powder |
Item |
Specification |
Test Results |
||
Description |
Off-white to light yellow powder |
Conforms |
||
Identification IR |
HPLC, IR |
Conform |
||
Specific optical rotation |
+68.0° ±3° (c=1.0, in Methanol) |
67.49° |
||
Melting point |
248±5 °C |
248 -250°C |
||
Water |
≤0.5% |
0.29% |
||
Heavy metals |
≤10ppm |
Conforms |
||
Residue on ignition |
Not more than 0.1% |
0.07% |
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Related substances |
Desfluoro aprepitant NMT 0.15% R,R,R-Diastereomer: NMT 0.15% Any other individual impurity: NMT 0.10% Total impurities: NMT 0.50% |
0.09% 0.08% 0.06% 0.29% |
||
Enantiomer purity |
NMT 0.15% of the S,R,S-enantiomer |
0.07% |
||
Assay (HPLC) |
NLT 98.0% and NMT 102.0% (on the anhydrous basis) |
99.9% |
||
Organic volatile impurities |
Methanol NMT 2500 ppm; Xylene NMT 2170 ppm; Toluene NMT 890 ppm; DMSO NMT 5000ppm |
Conforms |
||
Conclusion: Conforms to Authorized USP Pending Monograph |
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