5.Fluvastatins Sodium |
化学名称 :[3R ﹡ ,5S ﹡ -(E)]-( ± )-7-[3-(4- 氟苯基 )-1- 异丙基 -1H- 吲哚 -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 |
Heavy metals |
≤ 0.002% |
HPLC( Impurity) |
Fluvastatins Sodium anti-isomer |
≤ 0.5% |
Other Max individual |
≤ 0.2% |
Total |
≤ 1.0% |
Assay( on dry basis ) |
98.0-102% |
|