Methyl aminolevulinate Impurity 12 CAS CATO-C4X-299312

Description

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

Methyl aminolevulinate Impurity 12 (CAS CATO-C4X-299312) is a certified pharmaceutical impurity reference standard with the molecular formula C7H11NO5 and a molecular weight of 189.17 g/mol.

The molecular framework of Methyl aminolevulinate Impurity 12 (C7H11NO5) is characterized by an amino-acid-derived structure, 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 presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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 Methyl aminolevulinate Impurity 12 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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