Pemafibrate Impurity 56 CAS 765897-85-6

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.765897-85-6
Molecular FormulaC8H17NO2
Molecular Weight159.23 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Pemafibrate Impurity 56 CAS 765897-85-6 chemical structure

Description

Pemafibrate Impurity 56 (C8H17NO2) contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. The carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

As a process- or degradation-related impurity, Pemafibrate Impurity 56 (CAS 765897-85-6, C8H17NO2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

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 FormulaC8H17NO2
Molecular Weight159.23 g/mol
Purity≥95%
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)1.0
CAS Registry Year (est.)1986
Nitrogen Atoms1

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