Atorvastatin Impurity 157 (Disodium Salt)
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Lagerstandorte

  • New Jersey, USA
  • Czech Republic, EU
  • Mumbai, India

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Dokumentation

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Enthält: HPLC, MASS/LC-MS, 1H-NMR, FT-IR, Gehalt, Structure Elucidation Report (SER) sowie zusätzliche analytische Daten je nach Produkt.

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

Atorvastatin

IUPAC-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-diolate

Pharmacopeial Synonyms

N/A

Synonyme

2-Hydroxy Atorvastatin Disodium Salt

SMILES

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../s1

Beschreibung

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.

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