| CAS No. | 81-25-4 |
| Molecular Formula | C24H40O5 |
| Molecular Weight | 408.57 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
As a certified reference material (CRM), Ursodeoxycholic Acid EP Impurity B 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.
CATO supplies Ursodeoxycholic Acid EP Impurity B (CAS 81-25-4), a pharmacopoeial impurity reference standard (molecular formula C24H40O5, MW 408.57 g/mol) used for the identification and quantification of trace impurities in APIs.
Owing to a steroid core, a hydroxyl group, an ether linkage, Ursodeoxycholic Acid EP Impurity B is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 408.57 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.
| Molecular Formula | C24H40O5 |
| Molecular Weight | 408.57 g/mol |
| Appearance | Off-white to pale yellow crystalline powder |
| Purity | >95% |
| Storage | Store at room temperature, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | May oxidize slowly on prolonged air exposure |
| Degree of Unsaturation (DBE) | 5.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1957 |