Afatinib Impurity 56 CAS CATO-C4X-100656

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-100656
Molecular FormulaC7H16N2O3
Molecular Weight176.21 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Afatinib Impurity 56 CAS CATO-C4X-100656 chemical structure

Description

Afatinib Impurity 56 (C7H16N2O3) contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

Afatinib Impurity 56 (CAS CATO-C4X-100656) is a certified pharmaceutical impurity reference standard with the molecular formula C7H16N2O3 and a molecular weight of 176.21 g/mol.

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

Molecular FormulaC7H16N2O3
Molecular Weight176.21 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, ethanol, DMSO, water
StabilityLight-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)1.0
Nitrogen Atoms2

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