ATORVASTATIN CALCIUM |
Product Name |
: |
Atorvastatin Calcium BP/EP/USP |
Chemical Name |
: |
c[(3R,5R)-7-[3-(phenylcarbamoyl)-5-(4-fluorophenyl)-2-isoprotopyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid, calcium salt] |
CAS Number |
: |
134523-00-5 |
Chemical Formula |
: |
C33H35FN2O5 |
Molecular Mass |
: |
558.64 g/mol |
Therapeutic Category |
: |
Hypercholesterolmia |
Test |
Specification |
Description |
A white to off white crystalline powder |
Identification |
The infra-red absorbance spectrum should be concordant with the reference spectrum |
Solubility |
Freely soluble in methanol, slightly soluble in ethanol |
Heavy Metals |
NMT 20 ppm |
Assay on dried basis by HPLC |
NLT 98.0% AND NMT 102.0% |
Optical Rotation |
Between -6.0°and -12.0°on anhydrous basis |
Water Content by KF |
Between 3.0 and 7.0% w/w |
Related Substances by HPLC |
NMT 0.5% NMT 2.0% |
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