Ritodrine EP Impurity B (and enantiomer) CAS CATO-C4X-27431

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Ritodrine EP Impurity B (and enantiomer).

CATO supplies Ritodrine EP Impurity B (and enantiomer) (CAS CATO-C4X-27431), a pharmacopoeial impurity reference standard (molecular formula C17H25NO3, MW 291.39 g/mol) used for the identification and quantification of trace impurities in APIs.

Ritodrine EP Impurity B (and enantiomer) (C17H25NO3) contains a steroid core, an amide group, a hydroxyl group, an ether linkage. Its high carbon-to-hydrogen ratio confers good lipid solubility, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

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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