Sacubitril impurity 12 CAS 2459446-56-9

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.2459446-56-9
Molecular FormulaC18H19NO2
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Sacubitril impurity 12 CAS 2459446-56-9 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 317.81 g/mol gives Sacubitril impurity 12 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Sacubitril impurity 12 (CAS 2459446-56-9), a pharmacopoeial impurity reference standard (molecular formula C18H19NO2HCl, MW 317.81 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Sacubitril impurity 12 (C18H19NO2HCl) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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 manufactures Sacubitril impurity 12 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC18H19NO2 HCl
Molecular Weight317.81 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity>95%
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2000
Halogen ContentCl-containing
Nitrogen Atoms1

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