Erlotinib Impurity 108 CAS 311-28-4

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.311-28-4
Molecular FormulaC16H36N
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Erlotinib Impurity 108 CAS 311-28-4 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 369.37 g/mol gives Erlotinib Impurity 108 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

As a process- or degradation-related impurity, Erlotinib Impurity 108 (CAS 311-28-4, C16H36NI) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Erlotinib Impurity 108 (C16H36NI) contains iodine substitution. Halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility; 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.

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 FormulaC16H36N I
Molecular Weight369.37 g/mol
Purity>95%
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)-1.0
CAS Registry Year (est.)1957
Halogen ContentI-containing
Nitrogen Atoms1

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