| CAS No. | 61812-45-1 |
| Molecular Formula | C20H17FO2S |
| Molecular Weight | 340.41 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Sulindac Impurity 8 (CAS 61812-45-1) is a certified pharmaceutical impurity reference standard with the molecular formula C20H17FO2S and a molecular weight of 340.41 g/mol.
Structurally, Sulindac Impurity 8 (C20H17FO2S) contains a steroid core, a sulfone group, a hydroxyl group, an ether linkage, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 12.0, corresponding to approximately 12 ring(s) or double-bond equivalent(s). With a molecular weight of 340.41 g/mol, it falls into the moderately-high-molecular-weight range. 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.
As a certified reference material (CRM), Sulindac Impurity 8 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 | C20H17FO2S |
| Molecular Weight | 340.41 g/mol |
| Purity | >90% |
| Storage | Store at 2-8°C, 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) | 12.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1974 |
| Halogen Content | F-containing |
| Sulfur Atoms | 1 |