Teprenone impurity 46 CAS CATO-C4X-208146

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Teprenone impurity 46.

Teprenone impurity 46 (CAS CATO-C4X-208146) is a certified pharmaceutical impurity reference standard with the molecular formula C23H38O4 and a molecular weight of 378.55 g/mol.

Based on its molecular formula C23H38O4, Teprenone impurity 46 contains a steroid core, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 378.55 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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 Teprenone impurity 46 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

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