Sacubitril Impurity 57 CAS 556828-95-6

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Sacubitril Impurity 57.

CATO supplies Sacubitril Impurity 57 (CAS 556828-95-6), a certified reference material (molecular formula C18H17NO3, MW 295.33 g/mol) for analytical method development and quality control.

Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, Sacubitril Impurity 57 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 295.33 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

This reference standard is suitable for quantitative analysis on major chromatographic platforms including HPLC, GC, LC-MS/MS, and GC-MS, serving as an external calibration standard or a system suitability test reference material.

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

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