Bisacodyl Impurity 14 CAS 100378-86-7

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Bisacodyl Impurity 14.

Bisacodyl Impurity 14 (CAS 100378-86-7) is a certified pharmaceutical impurity reference standard with the molecular formula C8H10O4S and a molecular weight of 202.23 g/mol.

The molecular framework of Bisacodyl Impurity 14 (C8H10O4S) is characterized by a sulfone group, 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).

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.

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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