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Product name: Atorvastatin calcium
CAS No.: 134523-03-8 Molecular Structure:Molecular Structure of 134523-03-8 (Atorvastatin calcium) Formula: C66H68CaF2N4O10 Molecular Weight: 1209.42 .
Melting Point: 176-178 °C Boiling Point: 722.2 °C at 760 mmHg Flash Point: 390.6 °C Appearance: White Crystalline Powder
Application: Atorvastatin is a member of the drug class known as statins, used for lowering blood cholesterol. It also stabilizes plaque and prevents strokes through anti-inflammatory and other mechanisms. Like all statins, atorvastatin works by inhibiting HMG-CoA reductase, an enzyme found in liver tissue that plays a key role in production of cholesterol in the body.
Specification
TEST |
STANDARD |
RESULT |
Appearance: |
white or almost white powder, slightly hygroscopic, ordorless |
Confirms |
Very solutable in acetonitrile or chloroform, Soluble in Water, very soluble and practically insolutable in ethyl ether |
Confirms |
|
Identification |
(1) IR |
Conforms |
(2) HPLC |
Conforms |
|
Water |
NMT 5.0% |
0.6% |
Residue on ignition |
NMT 0.2% |
0.1% |
Methyl benzenesulfonate |
NMT 0.1% |
undetected |
Toluene |
NMT 890ppm (ICH) |
102ppm |
Chromatographic purity |
(1) Laudanosine: NMT 0.5% (2) Other individual impurities: NMT 1.0% (3) Total Impurities: NMT 3.5% |
0.01% 0.38% 1.3% |
Isomer Ratio |
Trans-Trans Isomer: 5%-6.5% |
5.7% |
|
Cis-Trans Isomer: 34.5%-38.5% |
36% |
|
Cis-Cis Isomer: 55%-60% |
58.2% |
Assay |
96%-102% (C65H82N2O18S2 on anhydrous basis) |
100.2% |
Residue Solvents |
(1) Dichloromethane: NMT 600ppm (2) Acctonitrile: NMT 410ppm (3) Ethyl ether: NMT 5000ppm |
Undetected Undetected 1739ppm |
Result |
Confirms to USP34 |
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