Atorvastatin Impurity 157 (Disodium Salt)
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| Katalog-Nr.:: | VE0026696 |
|---|---|
| CAS-Nr.:: | N/A |
| Summenformel:: | C33H35FN2Na2O6 |
| Molare Masse:: | 620.62 g/mol |
Zusätzliche Informationen zu
Parent drug
AtorvastatinIUPAC-Name
disodium;(3R,5R)-7-[2-(4-fluorophenyl)-4-[(2-hydroxycyclohexa-1,5-dien-1-yl)carbamoyl]-3-phenyl-5-propan-2-ylpyrrol-1-yl]-1-hydroxy-1-oxoheptane-3,5-diolatePharmacopeial Synonyms
N/ASynonyme
2-Hydroxy Atorvastatin Disodium SaltSMILES
OC1=C(NC(C2=C(C(C)C)N(CC[C@@H]([O-])C[C@@H]([O-])CC(O)=O)C(C3=CC=C(F)C=C3)=C2C4=CC=CC=C4)=O)C=CCC1.[Na+].[Na+]InChI
InChI=1S/C33H35FN2O6.2Na/c1-20(2)31-30(33(42)35-26-10-6-7-11-27(26)39)29(21-8-4-3-5-9-21)32(22-12-14-23(34)15-13-22)36(31)17-16-24(37)18-25(38)19-28(40)41;;/h3-6,8-10,12-15,20,24-25,39H,7,11,16-19H2,1-2H3,(H,35,42)(H,40,41);;/q-2;2*+1/t24-,25-;;/m1../s1Beschreibung
Atorvastatin Impurity 157, identified as 2-Hydroxy Atorvastatin disodium salt, is a hydroxylated structural analogue arising during synthesis or oxidative degradation of atorvastatin. This polar degradation product can alter impurity profile, solid-state properties, and analytical quantitation if not controlled. It is routinely monitored by HPLC-UV with orthogonal confirmation by LC-MS and NMR to establish identity and purity. Formation pathways include inadvertent oxidation or base-catalyzed hydrolysis under process or storage conditions. Effective control strategies include optimized reaction quenching, antioxidant use, targeted purification steps such as preparative chromatography, and validated analytical methods aligned with ICH impurity guidelines.Angebot anfordern
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