Ramosetron Hydrochloride
Product name (1-Methyl-1H-indol-3-yl)[(5R)-4,5,6,7-tetrahydro-1H-benzimidazol-5-
yl]methanone hydrochloride
Structure
Molecular Formula C17H17N3O·HCl
Molecular Weight 315.80.
CAS Number 132907-72-3
NMPA approval No. H20055083
National Drug standards WS1-(X-170)-2012Z
|
Test |
CP |
Results |
|
Color & Appearance |
White to yellowish crystalline powder |
white crystalline powder |
|
Specific rotation |
-39°~ -44° |
-42° |
|
Assay (HPLC ) |
NLT 98.5 % |
99.5 % |
|
Total impurities (HPLC) |
NMT 0.5% |
0. 2 % |
|
Unkown impurities Optical isomers |
NMT 0.2% NMT 0.4 % |
0.1% Conforms |
|
Residual solvents |
|
|
|
Methanol |
NMT 0.3% |
Conforms |
|
N, N - dimethyl formamide (DMF) Dichloromethane |
NMT 0.088% NMT0.06% |
Conforms Conforms |
|
Loss on Drying |
NMT 1.0 % ( 105 ℃) |
0.6 % |
|
Residue on ignition |
NMT 0.1% |
0.05% |
|
Heavy metals (as Pb) |
NMT 10 ppm |
Conforms |
Package: 1kg
storage ：Preserve in tight light-resistant containers .