| CAS No. | 16133-49-6 |
| Molecular Formula | C7H8N2O3 |
| Molecular Weight | 168.15 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Esomeprazole Impurity 44.
Esomeprazole Impurity 44 (CAS 16133-49-6) is a certified pharmaceutical impurity reference standard with the molecular formula C7H8N2O3 and a molecular weight of 168.15 g/mol.
Owing to an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage, Esomeprazole Impurity 44 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 168.15 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.
As a certified reference material (CRM), Esomeprazole Impurity 44 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.
| Molecular Formula | C7H8N2O3 |
| Molecular Weight | 168.15 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 methanol, ethanol, DMSO, water |
| 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.) | 1961 |
| Nitrogen Atoms | 2 |