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Atorvastatin 5-Isopropyl Ether tert-Butyl Ester

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Katalog-Nr.::	VE0026708
CAS-Nr.::	N/A
Summenformel::	C40H49FN2O5
Molare Masse::	656.8 g/mol

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Zusätzliche Informationen zu

Parent drug

Atorvastatin

IUPAC-Name

Tert-butyl (3R,5R)-7-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-propan-2-ylpyrrol-1-yl]-3-hydroxy-5-propan-2-yloxyheptanoate

Pharmacopeial Synonyms

N/A

Synonyme

N/A

SMILES

O=C(C1=C(C(C)C)N(CC[C@H](C[C@H](CC(OC(C)(C)C)=O)O)OC(C)C)C(C2=CC=C(F)C=C2)=C1C3=CC=CC=C3)NC4=CC=CC=C4

InChI

InChI=1S/C40H49FN2O5/c1-26(2)37-36(39(46)42-31-16-12-9-13-17-31)35(28-14-10-8-11-15-28)38(29-18-20-30(41)21-19-29)43(37)23-22-33(47-27(3)4)24-32(44)25-34(45)48-40(5,6)7/h8-21,26-27,32-33,44H,22-25H2,1-7H3,(H,42,46)/t32-,33-/m1/s1

Beschreibung

Atorvastatin 5-Isopropyl Ether tert-Butyl Ester impurity is a process-related synthetic byproduct encountered during atorvastatin esterification and alkylation steps. Characterized by LC-MS and confirmed by 1H and 13C NMR, this lipophilic ester impurity can form from incomplete deprotection or over-alkylation of the isopropyl ether intermediate and may coelute with target analytes, affecting assay accuracy and stability profiles. Routine impurity profiling by validated reverse-phase HPLC with MS detection is recommended, alongside control measures such as optimized stoichiometry, selective protection-deprotection strategies and purification by column chromatography or preparative HPLC, with qualification aligned to ICH impurity thresholds and risk assessment.