atorvastatin calcium 134523-03-8 Lipitor
Certificate of analysis
atorvastatin calcium pharmaceuticals
Test Items |
Standard |
Character |
A white or almost white amorphous powder |
Specific Optical Rotation |
-7.0°~9.0° |
Water |
≤3.5% |
SOLUBILITY |
40 °C Soluble in tetrahydrofuran, 20 °C,slightly soluble in water, Insoluble in ether |
PARTICLE SIZE |
180-150μm |
Ca % |
3.0~3.6 |
Heavy Metals(ppm) |
≤10 |
X-RAY Diffraction |
amorphous |
Impurity (HPLC)
|
Atorvastatin Lactone ≤0.1% Desfluoro-atorvastatin calcium ≤0.2% Diamine –atorvastatin calcium ≤0.3% Isomer-atorvastatin calcium ≤0.2% Other individual unknown Impurity %≤0.2% Total impurities≤1.0% |
Assay |
98.0-102.0% |
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