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581772-29-4Atorvastatin EP Impurity P (Free Base)

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Catalogue No.:	VE006450
CAS No.:	581772-29-4
Mol. Formula:	C36H39FN2O5
Mol. Weight:	598.70 g/mol

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Additional information on CAS 581772-29-4

Parent drug

Atorvastatin

IUPAC Name

[(4R,6R)-6-[2-[2-(4-fIuorophenyI)-3-phenyI-4-(phenyIcarbamoyI)-5-(propan-2-yI)-1H-pyrroI-1-yI]ethyI]-2,2- dimethyI-1,3-dioxan-4-yI]acetic acid

Synonyms

Atorvastatin Acetonide Impurity; Atorvastatin Impurity 2

Smiles

O=C(O)C[C@@H]1OC(C)(C)O[C@H](CCN2C(C3=CC=C(F)C=C3)=C(C4=CC=CC=C4)C(C(NC5=CC=CC=C5)=O)=C2C(C)C)C1

Pharmacopeial Synonyms

N/A

InChI

InChI=1S/C36H39FN2O5/c1-23(2)33-32(35(42)38-27-13-9-6-10-14-27)31(24-11-7-5-8-12-24)34(25-15-17-26(37)18-16-25)39(33)20-19-28-21-29(22-30(40)41)44-36(3,4)43-28/h5-18,23,28-29H,19-22H2,1-4H3,(H,38,42)(H,40,41)/t28-,29-/m1/s1

Description

Atorvastatin EP Impurity P, also designated Atorvastatin Acetonide or Atorvastatin Impurity-2, CAS 581772-29-4, is a structurally related synthetic process impurity of atorvastatin bearing an acetonide-protected diol motif within the side chain. Its molecular formula is C36H39FN2O5 with a molecular weight of 598.70 g/mol. The impurity is generally associated with incomplete deprotection or side reactions during semi-synthetic manufacture rather than oxidative degradation. Because of close structural similarity to the API, characterization commonly relies on LC-MS/MS, HPLC with diode-array detection, and, where needed, NMR for site-specific assignment. It is evaluated within impurity profiling frameworks rather than as a genotoxic alert species.