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Includes: HPLC, MASS/LC-MS, 1H NMR, FT-IR, Potency, Structure Elucidation Report (SER), and additional analytical data depending on the product.

Atorvastatin Impurity 157 (Disodium Salt)

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Catalogue No.:	VE0026696
CAS No.:	N/A
Mol. Formula:	C33H35FN2Na2O6
Mol. Weight:	620.62 g/mol

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Additional information on

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

Synonyms

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

Description

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.