|
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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