| Customization: | Available |
|---|---|
| Function: | Antibiotic and Antimicrobial Agents, Blood System Agents |
| Certification: | GMP |
|
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Atorvastatin calcium
CAS No: 134523-03-8
Purity: 99%
color: white
|
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% |
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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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