Capecitabine Impurity 50 CAS 13039-75-3

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.13039-75-3
Molecular FormulaC5H10O4
Molecular Weight134.13 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Capecitabine Impurity 50 CAS 13039-75-3 chemical structure

Description

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.

As a process- or degradation-related impurity, Capecitabine Impurity 50 (CAS 13039-75-3, C5H10O4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

The molecular framework of Capecitabine Impurity 50 (C5H10O4) is characterized by a carbohydrate-derived structure. 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.

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.

Physical & Chemical Properties

Molecular FormulaC5H10O4
Molecular Weight134.13 g/mol
Purity>95%
StorageStore at 2-8°C, keep sealed and dry
Solubility (reference)Soluble in methanol, ethanol, DMSO, water
StabilityHygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)1.0
CAS Registry Year (est.)1960

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