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内容: HPLC、MASS/LC-MS、1H NMR、FT-IR、含量、構造解析レポート（SER）、および製品に応じた追加分析データ。

Atorvastatin Impurity 157 (Disodium Salt)

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カタログ番号:	VE0026696
CAS番号:	N/A
分子式:	C33H35FN2Na2O6
分子量:	620.62 g/mol

見積もり依頼

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に関する追加情報

親薬物

Atorvastatin

IUPAC名

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

同義語

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

説明

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.