| CAS No. | 1665-65-2 |
| Molecular Formula | C8H14O4S2 |
| Molecular Weight | 238.32 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
FCN437 Impurity 1 (CAS 1665-65-2) is a certified pharmaceutical impurity reference standard with the molecular formula C8H14O4S2 and a molecular weight of 238.32 g/mol.
FCN437 Impurity 1 (C8H14O4S2) contains a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions.
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), FCN437 Impurity 1 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 | C8H14O4S2 |
| Molecular Weight | 238.32 g/mol |
| Purity | >95% |
| Storage | Store in a cool place (≤25°C), keep sealed and dry |
| Solubility (reference) | Soluble in methanol, ethanol, DMSO |
| Stability | Hygroscopic; reseal immediately after opening |
| Degree of Unsaturation (DBE) | 2.0 |
| CAS Registry Year (est.) | 1957 |
| Sulfur Atoms | 2 |