Melphalan EP Impurity I CAS 573704-40-2

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.573704-40-2
Molecular FormulaC14H21ClN2O3
Molecular Weight300.78 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Melphalan EP Impurity I CAS 573704-40-2 chemical structure

Description

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.

CATO supplies Melphalan EP Impurity I (CAS 573704-40-2), a pharmacopoeial impurity reference standard (molecular formula C14H21ClN2O3, MW 300.78 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C14H21ClN2O3, Melphalan EP Impurity I contains a nitrogen-containing heterocyclic scaffold, 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 300.78 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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 FormulaC14H21ClN2O3
Molecular Weight300.78 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor)
Purity>90%
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)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1984
Halogen ContentCl-containing
Nitrogen Atoms2

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