Pemafibrate Impurity 11 CAS 20852-38-4

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.20852-38-4
Molecular FormulaC11H14N2O
Molecular Weight190.24 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Pemafibrate Impurity 11 CAS 20852-38-4 chemical structure

Description

This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.

CATO supplies Pemafibrate Impurity 11 (CAS 20852-38-4), a pharmacopoeial impurity reference standard (molecular formula C11H14N2O, MW 190.24 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Pemafibrate Impurity 11 (C11H14N2O) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 6.0, corresponding to approximately 6 ring(s) or double-bond equivalent(s). With a molecular weight of 190.24 g/mol, it falls into the medium-molecular-weight range. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

Molecular FormulaC11H14N2O
Molecular Weight190.24 g/mol
Purity>95%
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1962
Nitrogen Atoms2

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