Lumateperone Impurity 12 CAS CATO-C4X-220112

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-220112
Molecular FormulaC17H23N3O2
Molecular Weight301.38 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Lumateperone Impurity 12 CAS CATO-C4X-220112 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Lumateperone Impurity 12.

CATO supplies Lumateperone Impurity 12 (CAS CATO-C4X-220112), a pharmacopoeial impurity reference standard (molecular formula C17H23N3O2, MW 301.38 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Lumateperone Impurity 12 (C17H23N3O2) is characterized by a steroid core, an amide 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. 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.

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 FormulaC17H23N3O2
Molecular Weight301.38 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 DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)8.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms3

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