Mexiletine EP Impurity C DiHCl CAS 2059988-39-3

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.2059988-39-3
Molecular FormulaC22H32N2O2
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Mexiletine EP Impurity C DiHCl CAS 2059988-39-3 chemical structure

Description

Mexiletine EP Impurity C DiHCl (CAS 2059988-39-3) is a certified pharmaceutical impurity reference standard with the molecular formula C22H32N2O2HCl and a molecular weight of 392.97 g/mol.

Based on its molecular formula C22H32N2O2HCl, Mexiletine EP Impurity C DiHCl contains a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 392.97 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.

As a certified reference material (CRM), Mexiletine EP Impurity C DiHCl 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 FormulaC22H32N2O2 2*HCl
Molecular Weight392.97 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor)
Purity>95%
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)7.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1997
Halogen ContentCl-containing
Nitrogen Atoms2

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