| CAS No. | 915095-94-2 |
| Molecular Formula | C17H16ClIO2 |
| Molecular Weight | 414.67 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 Empagliflozin Impurity 50.
Empagliflozin Impurity 50 (CAS 915095-94-2) is a certified pharmaceutical impurity reference standard with the molecular formula C17H16ClIO2 and a molecular weight of 414.67 g/mol.
Based on its molecular formula C17H16ClIO2, Empagliflozin Impurity 50 contains a steroid core, a hydroxyl group, an ether linkage, chlorine/iodine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 414.67 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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), Empagliflozin Impurity 50 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 | C17H16ClIO2 |
| Molecular Weight | 414.67 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | >95% |
| Storage | Store at room temperature, protect from light |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 9.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1987 |
| Halogen Content | Cl/I-containing |