Sacubitril impurity 52 CAS CATO-C4X-280952

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-280952
Molecular FormulaC25H31NO3
Molecular Weight393.52 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Sacubitril impurity 52 CAS CATO-C4X-280952 chemical structure

Description

Structurally, Sacubitril impurity 52 (C25H31NO3) contains a steroid core, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 11.0, corresponding to approximately 11 ring(s) or double-bond equivalent(s). With a molecular weight of 393.52 g/mol, it falls into the moderately-high-molecular-weight range. 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, Sacubitril impurity 52 (CAS CATO-C4X-280952, C25H31NO3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

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.

As a certified reference material (CRM), Sacubitril impurity 52 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC25H31NO3
Molecular Weight393.52 g/mol
AppearancePale yellow to yellow crystalline powder
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)11.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms1

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