| CAS No. | 156077-56-4 |
| Molecular Formula | C12H28N4O3 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
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.
CATO supplies Gadobutrol Impurity 125 (CAS 156077-56-4), a pharmacopoeial impurity reference standard (molecular formula C12H28N4O3HCl, MW 312.84 g/mol) used for the identification and quantification of trace impurities in APIs.
Owing to an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution, Gadobutrol Impurity 125 is typically white to off-white crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 312.84 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
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.
| Molecular Formula | C12H28N4O3 4*HCl |
| Molecular Weight | 312.84 g/mol |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 0.0 |
| CAS Registry Year (est.) | 2001 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 4 |