Atorvastatin Impurity 56 CAS 2088732-01-6

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.2088732-01-6
Molecular FormulaC14H27NO4
Molecular Weight273.37 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Atorvastatin Impurity 56 CAS 2088732-01-6 chemical structure

Description

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.

CATO supplies Atorvastatin Impurity 56 (CAS 2088732-01-6), a pharmacopoeial impurity reference standard (molecular formula C14H27NO4, MW 273.37 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Atorvastatin Impurity 56 (C14H27NO4) is characterized by an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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.

Physical & Chemical Properties

Molecular FormulaC14H27NO4
Molecular Weight273.37 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityLight-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)2.0
CAS Registry Year (est.)1997
Nitrogen Atoms1

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