Methyl Salicylate EP Impurity L CAS 33528-09-5

Description

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 supplies Methyl Salicylate EP Impurity L (CAS 33528-09-5), a pharmacopoeial impurity reference standard (molecular formula C9H10O3, MW 166.17 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Methyl Salicylate EP Impurity L (C9H10O3) is characterized by a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system. In reversed-phase chromatography, its retention is governed primarily by the polarity and ionization state of its functional 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).

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

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