Eltrombopag Impurity 55 CAS 13636-53-8

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Eltrombopag Impurity 55.

Eltrombopag Impurity 55 (CAS 13636-53-8) is a certified pharmaceutical impurity reference standard with the molecular formula C8H12N2 and a molecular weight of 136.19 g/mol.

Structurally, Eltrombopag Impurity 55 (C8H12N2) contains a nitrogen-containing heterocyclic scaffold, a nitrile group. The molecule exhibits a degree of unsaturation (DBE) of 4.0, corresponding to approximately 4 ring(s) or double-bond equivalent(s). With a molecular weight of 136.19 g/mol, it falls into the low-molecular-weight range. 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 Eltrombopag Impurity 55 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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