Atorvastatin EP Impurity G
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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.

887324-53-0Atorvastatin EP Impurity G

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Catalogue No.:VE009827
CAS No.:887324-53-0
Mol. Formula:C34H37FN2O5
Mol. Weight:572.67 g/mol

Additional information on CAS 887324-53-0

Parent drug

Atorvastatin

IUPAC Name

(3R,5R)-7-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]-5-hydroxy-3-methoxyheptanoic acid

Pharmacopeial Synonyms

3-O-Methyl Atorvastatin

Other Synonyms

(3R,5R)-7-(2-(4-Fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)-5-hydroxy-3-methoxyheptanoicacid

Smiles

O=C(O)C[C@H](OC)C[C@H](O)CCN1C(C2=CC=C(F)C=C2)=C(C3=CC=CC=C3)C(C(NC4=CC=CC=C4)=O)=C1C(C)C

InChI

InChI=1S/C34H37FN2O5/c1-22(2)32-31(34(41)36-26-12-8-5-9-13-26)30(23-10-6-4-7-11-23)33(24-14-16-25(35)17-15-24)37(32)19-18-27(38)20-28(42-3)21-29(39)40/h4-17,22,27-28,38H,18-21H2,1-3H3,(H,36,41)(H,39,40)/t27-,28-/m1/s1

Description

Atorvastatin EP Impurity G, also designated 3-O-Methyl Atorvastatin (Free Base), CAS 887324-53-0, is a structurally related process- and degradation-associated impurity of the statin scaffold rather than a separate reactive class such as a nitrosamine. With molecular formula C34H37FN2O5 and molecular weight 572.67 g/mol, it differs from atorvastatin by O-methylation at the 3-hydroxy substituent, altering polarity and chromatographic behavior. Its origin may reflect incomplete deprotection, methyl-transfer side reactions, or metabolic-like O-alkylation. Trace-level characterization typically requires LC-MS/MS, high-resolution LC-MS, and orthogonal HPLC-UV methods; impurity assignment is managed within pharmacopoeial specifications and related ICH impurity control frameworks.

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