Language
Grade: Pharmaceutical Grade
Factory Location: Xiamen, Fujian
Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East
Monthly Production Capacity: 1000kg
Packaging Information: 25kg/drum 1kg/bottle
Delivery Lead Time: 7 days after payment
Sample Provided: yes
Payment Terms: L/L
Product Information |
Product name |
Rosuvastatin Calcium |
CAS No. |
147098-20-2 |
Molecular Formula |
C44H54CaF2N6O12S2 |
Molecular Weight |
1001.14 |
Quality Standard |
97% up by HPLC, GMP,DMF,CEP, EP |
Appearance |
White or almost white powder |
COA of Rosuvastatin calcium |
ITEMS |
SPECIFICATION |
RESULT |
Appearance |
White or almost white hygroscopic powder |
Conforms |
Identity |
IR: Similar to Reference Substance |
Conforms |
Enantiomeric purity |
Conforms |
|
It gives reaction (b) of calcium |
Positive reaction |
|
Related substance |
Impurity A ≤ 0.2%Impurity B ≤ 0.5%Impurity C ≤ 0.8%Unknown impurity ≤ 0.1%Total impurity ≤ 1.2% |
UndetectedUndetectedUndetectedUndetectedUndetected |
Enantiomer |
Impurity G ≤ 0.10% |
Undetected |
Water |
≤ 0.60% |
1.2% |
Assay |
97.0～102.0%(anhydrous substance ) |
99.9% |
Conclusion |
The results above meet all requirements under EP8.4 |
|
Usage |
