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42017-89-0Fenofibrate EP Impurity B

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Catalogue No.:	VL59002
CAS No.:	42017-89-0
Mol. Formula:	C17H15ClO4
Mol. Weight:	318.75 g/mol

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Additional information on CAS 42017-89-0

Parent drug

Fenofibrate

IUPAC Name

2-[4-(4-Chlorobenzoyl)phenoxy]-2-methylpropanoic acid

Pharmacopeial Synonyms

Fenofibrate Related Compound B

Synonyms

Fenofibric Acid

Smiles

CC(C)(OC1=CC=C(C(C2=CC=C(Cl)C=C2)=O)C=C1)C(O)=O

InChI

InChI=1S/C17H15ClO4/c1-17(2,16(20)21)22-14-9-5-12(6-10-14)15(19)11-3-7-13(18)8-4-11/h3-10H,1-2H3,(H,20,21)

Shipping Condition

Ambient Temperature

Description

Fenofibrate EP Impurity B, also designated Fenofibrate Related Compound B and fenofibric acid, corresponds to CAS 42017-89-0 and has molecular formula C17H15ClO4 with molecular weight 318.75 g/mol. Structurally, it is the hydrolyzed carboxylic acid metabolite of fenofibrate, arising from ester cleavage during synthesis, storage, or oxidative hydrolysis rather than from a novel scaffold. Because it is a process- and degradation-related impurity, its characterization generally relies on LC-MS/MS for identity confirmation and LC-UV or HPLC with reference comparison for assay determination; GC-MS may be used after derivatization. It is not a nitrosamine and is not typically discussed under ICH M7 genotoxic impurity classes.