Doxofylline Impurity 42 CAS 56548-04-0

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.56548-04-0
Molecular FormulaC8H19NO4
Molecular Weight193.24 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Doxofylline Impurity 42 CAS 56548-04-0 chemical structure

Description

The occurrence of Doxofylline Impurity 42 is closely related to an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Doxofylline Impurity 42 (CAS 56548-04-0, C8H19NO4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Doxofylline Impurity 42 (C8H19NO4) 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.

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.

As a certified reference material (CRM), Doxofylline Impurity 42 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

Molecular FormulaC8H19NO4
Molecular Weight193.24 g/mol
Purity>95%
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)0.0
CAS Registry Year (est.)1973
Nitrogen Atoms1

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