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1105067-88-6Atorvastatin EP Impurity E (Ca Salt)

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Catalogue No.:	VL10006
CAS No.:	1105067-88-6
Mol. Formula:	C66H68CaF2N4O10
Mol. Weight:	1155.34 g/mol

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Additional information on CAS 1105067-88-6

Parent drug

Atorvastatin

IUPAC Name

(35,55)-7-[2-(4-fIuorophenyI)-3-phenyI-4-(phenyIcarbamoyI)-5-(propan-2-yI)-1 H-pyrroI-1-yI]-3,5- dihydroxyheptanoic acid calcium salt

Synonyms

Atorvastatin 3S, 5S ISOMER; Atorvastatin (3S,5S)-enantiomer (Ca Salt)

Pharmacopeial Synonyms

Atorvastatin Related Compound E; Ent-Atorvastatin (Ca Salt)

Smiles

CC(C)C1=C(C(=C(N1CCC(CC(CC(=O)[O-])O)O)C2=CC=C(C=C2)F)C3=CC=CC=C3)C(=O)NC4=CC=CC=C4.CC(C)C1=C(C(=C(N1CCC(CC(CC(=O)[O-])O)O)C2=CC=C(C=C2)F)C3=CC=CC=C3)C(=O)NC4=CC=CC=C4.[Ca+2]

Description

Atorvastatin Related Compound E, also designated Atorvastatin EP Impurity E, Ent-Atorvastatin, and the Atorvastatin 3S,5S isomer calcium salt, is the stereochemical enantiomer of atorvastatin rather than a degradative fragment or mutagenic alert structure. CAS 1105067-88-6; molecular formula C66H68CaF2N4O10; molecular weight 1155.34 g/mol. Its presence typically reflects stereochemical inversion or carryover from asymmetric synthesis and requires distinction from the pharmacologically active 3R,5R configuration. Trace-level characterization generally relies on chiral LC, LC-MS/MS, and high-resolution MS to resolve isomeric and salt-associated species. Regulatory assessment focuses on stereochemical purity, impurity profiling, and quantitative limits derived from process capability and stability studies.