Valaciclovir EP Impurity I CAS 102728-64-3

Description

Compared with other compounds in its class, the molecular weight of 267.24 g/mol gives Valaciclovir EP Impurity I distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

Valaciclovir EP Impurity I (CAS 102728-64-3) is a certified pharmaceutical impurity reference standard with the molecular formula C10H13N5O4 and a molecular weight of 267.24 g/mol.

Owing to an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage, Valaciclovir EP Impurity I is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 267.24 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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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