Item |
Standard |
|
Descripition |
light yellow powder |
|
Identification |
A. IR-Spectrum |
|
Water |
≤ 5.0% |
|
PH |
8.0-10.0 |
|
Heavy metals |
≤ 0.002% |
|
HPLC( Impurity) |
Fluvastatin sodium anti-isomer |
≤ 0.8% |
Other Max individual |
≤ 0.2% |
|
Total |
≤ 1.0% |
|
Assay( on dry basis ) |
98.0-102% |