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Atorvastatin Cyclic Fluorophenyl Impurity(Calcium Salt)

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Katalog-Nr.::	VE0026804
CAS-Nr.::	N/A
Summenformel::	C66H68CaF2N4O14
Molare Masse::	1219.34 g/mol

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Zusätzliche Informationen zu

Parent drug

Atorvastatin

IUPAC-Name

calcium bis((3R)-4-[1-(4-fluorophenyl)-5-hydroxy-2-phenyl-4-(phenylcarbamoyl)-5-propan-2-yl-3,10-dioxa-6-azatricyclo[4.4.0.02,4]decan-9-yl]-3-hydroxybutanoate)

SMILES

CC(C1(O)C2(C(NC3=CC=CC=C3)=O)C(C4(C5=CC=CC=C5)N1CCC(C[C@@H](O)CC([O-])=O)O4)(C6=CC=C(F)C=C6)O2)C.CC(C7(O)C8(C(NC9=CC=CC=C9)=O)C(C%10(C%11=CC=CC=C%11)N7CCC(C[C@@H](O)CC([O-])=O)O%10)(C%12=CC=C(F)C=C%12)O8)C.[Ca+2]

InChI

InChI=1S/2C33H35FN2O7.Ca/c2*1-21(2)32(41)31(29(40)35-25-11-7-4-8-12-25)30(43-31,22-13-15-24(34)16-14-22)33(23-9-5-3-6-10-23)36(32)18-17-27(42-33)19-26(37)20-28(38)39;/h2*3-16,21,26-27,37,41H,17-20H2,1-2H3,(H,35,40)(H,38,39);/q;;+2/p-2/t2*26-,27?,30?,31?,32?,33?;/m11./s1

Beschreibung

Atorvastatin cyclic fluorophenyl impurity calcium salt is a process-related impurity observed during atorvastatin synthesis and drug product processing. Defined by a cyclic fluorophenyl core and calcium counterion, this impurity presents specific analytical challenges and distinct chromatographic behavior in reversed-phase HPLC. Identification typically requires orthogonal techniques such as LC-MS, 19F and 1H NMR and elemental analysis to confirm fluorine content and metal association. Effective control relies on reaction parameter optimization, enhanced purification steps, raw material qualification and validated analytical methods for quantification. Establishing specification limits, forced-degradation and stability profiling are critical to mitigate risk and ensure regulatory compliance for impurity profiles.