Zolpidem Tartrate EP Impurity C CAS 4619-20-9

Description

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

As a process- or degradation-related impurity, Zolpidem Tartrate EP Impurity C (CAS 4619-20-9, C11H12O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Zolpidem Tartrate EP Impurity C (C11H12O3) contains a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system. It is notably hygroscopic, 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 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.

As a certified reference material (CRM), Zolpidem Tartrate EP Impurity C meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

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