Ranitidine Impurity 14 CAS 84167-82-5

Description

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

Ranitidine Impurity 14 (CAS 84167-82-5) is a certified pharmaceutical impurity reference standard with the molecular formula C10H18N2O and a molecular weight of 182.26 g/mol.

Owing to an amide group, a hydroxyl group, an ether linkage, Ranitidine Impurity 14 is typically white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 182.26 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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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