化学名称 :[3R ﹡ ,5S ﹡ -(E)]-( &plu***n; )-7-[3-(4- 氟*** )-1- *** -1H- *** -2- 基 ]-3,5- 二羟基 -6- 庚烯酸钠
Sodium(+-) (E)-3,5-dihydroxy-7-[3'-(4"-fluorophenyl)-1'-methylethyl-indol-2'-yl] hept-6-enoate
|
Item |
Standard | |
|
Descripition |
light yellow powder | |
|
Identification |
A. IR-Spectrum B. UV |
|
|
Water |
≤ 5.0% | |
|
PH |
8.0-10.0 | |
|
He***y metals |
≤ 0.002% | |
|
HPLC( Impurity) |
Fluvastatin sodium anti-isomer |
≤ 0.5% |
|
Other Max individual |
≤ 0.2% | |
|
Total |
≤ 1.0% | |
|
Assay( on dry basis )
|
98.0-102% | |