Methotrexate impurity N4 CAS 54643-27-5

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.54643-27-5
Molecular FormulaC7H8N6O2
Molecular Weight208.18 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Methotrexate impurity N4 CAS 54643-27-5 chemical structure

Description

CATO supplies Methotrexate impurity N4 (CAS 54643-27-5), a pharmacopoeial impurity reference standard (molecular formula C7H8N6O2, MW 208.18 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage, Methotrexate impurity N4 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 208.18 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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 FormulaC7H8N6O2
Molecular Weight208.18 g/mol
AppearanceOff-white to pale yellow crystalline powder. (faint amine-like odor)
Purity97%+
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
Degree of Unsaturation (DBE)7.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1972
Nitrogen Atoms6

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