| CAS No. | 54643-27-5 |
| Molecular Formula | C7H8N6O2 |
| Molecular Weight | 208.18 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
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.
| Molecular Formula | C7H8N6O2 |
| Molecular Weight | 208.18 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (faint amine-like odor) |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening |
| Degree of Unsaturation (DBE) | 7.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1972 |
| Nitrogen Atoms | 6 |