| CAS No. | 6633-36-9 |
| Molecular Formula | C8H10N2O2 |
| Molecular Weight | 166.18 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
CATO supplies Bumetanide Impurity 43 (CAS 6633-36-9), a pharmacopoeial impurity reference standard (molecular formula C8H10N2O2, MW 166.18 g/mol) used for the identification and quantification of trace impurities in APIs.
The molecular framework of Bumetanide Impurity 43 (C8H10N2O2) is characterized by an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
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 | C8H10N2O2 |
| Molecular Weight | 166.18 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (faint amine-like odor) |
| Purity | >95% |
| 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) | 5.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1958 |
| Nitrogen Atoms | 2 |