| CAS No. | 81131-74-0 |
| Molecular Formula | C23H36O7 |
| Molecular Weight | 424.53 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Pravastatin Impurity 59 (CAS 81131-74-0) is a certified pharmaceutical impurity reference standard with the molecular formula C23H36O7 and a molecular weight of 424.53 g/mol.
The molecular framework of Pravastatin Impurity 59 (C23H36O7) is characterized by a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system. In reversed-phase chromatography, its retention is governed primarily by the polarity and ionization state of its functional groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).
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), Pravastatin Impurity 59 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 | C23H36O7 |
| Molecular Weight | 424.53 g/mol |
| Appearance | Off-white to pale yellow crystalline powder |
| Purity | 97%+ |
| Storage | Store at room temperature, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 6.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1980 |