Penicillamine EP Impurity A CAS 20902-45-8

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.20902-45-8
Molecular FormulaC10H20N2O4S2
Molecular Weight296.41 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Penicillamine EP Impurity A CAS 20902-45-8 chemical structure

Description

As a process- or degradation-related impurity, Penicillamine EP Impurity A (CAS 20902-45-8, C10H20N2O4S2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Based on its molecular formula C10H20N2O4S2, Penicillamine EP Impurity A contains an amide group, a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage; these features give the compound characteristic functional-group stretching vibrations in infrared spectroscopy. The molecular weight of 296.41 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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

Molecular FormulaC10H20N2O4S2
Molecular Weight296.41 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, ethanol, DMSO
StabilityLight-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)2.0
CAS Registry Year (est.)1962
Nitrogen Atoms2
Sulfur Atoms2

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