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포함 사항: HPLC, MASS/LC-MS, 1H NMR, FT-IR, 함량, 구조 규명 보고서(SER), 그리고 제품에 따라 추가 분석 데이터가 제공됩니다.

Atorvastatin Impurity 157 (Disodium Salt)

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카탈로그 번호:	VE0026696
CAS 번호:	N/A
분자식:	C33H35FN2Na2O6
분자량:	620.62 g/mol

견적 요청

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모약물

Atorvastatin

IUPAC명

disodium;(3R,5R)-7-[2-(4-fluorophenyl)-4-[(2-hydroxycyclohexa-1,5-dien-1-yl)carbamoyl]-3-phenyl-5-propan-2-ylpyrrol-1-yl]-1-hydroxy-1-oxoheptane-3,5-diolate

Pharmacopeial Synonyms

N/A

동의어

2-Hydroxy Atorvastatin Disodium Salt

SMILES

OC1=C(NC(C2=C(C(C)C)N(CC[C@@H]([O-])C[C@@H]([O-])CC(O)=O)C(C3=CC=C(F)C=C3)=C2C4=CC=CC=C4)=O)C=CCC1.[Na+].[Na+]

InChI

InChI=1S/C33H35FN2O6.2Na/c1-20(2)31-30(33(42)35-26-10-6-7-11-27(26)39)29(21-8-4-3-5-9-21)32(22-12-14-23(34)15-13-22)36(31)17-16-24(37)18-25(38)19-28(40)41;;/h3-6,8-10,12-15,20,24-25,39H,7,11,16-19H2,1-2H3,(H,35,42)(H,40,41);;/q-2;2*+1/t24-,25-;;/m1../s1

설명

Atorvastatin Impurity 157, identified as 2-Hydroxy Atorvastatin disodium salt, is a hydroxylated structural analogue arising during synthesis or oxidative degradation of atorvastatin. This polar degradation product can alter impurity profile, solid-state properties, and analytical quantitation if not controlled. It is routinely monitored by HPLC-UV with orthogonal confirmation by LC-MS and NMR to establish identity and purity. Formation pathways include inadvertent oxidation or base-catalyzed hydrolysis under process or storage conditions. Effective control strategies include optimized reaction quenching, antioxidant use, targeted purification steps such as preparative chromatography, and validated analytical methods aligned with ICH impurity guidelines.