Oseltamivir Impurity 61 CAS 2413185-89-2

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Oseltamivir Impurity 61.

As a process- or degradation-related impurity, Oseltamivir Impurity 61 (CAS 2413185-89-2, C14H22O4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system, Oseltamivir Impurity 61 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 254.32 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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 Oseltamivir Impurity 61 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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