| CAS No. | CATO-C4X-15477 |
| Molecular Formula | C19H28O8 |
| Molecular Weight | 384.42 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 Artesunate Impurity 7.
CATO supplies Artesunate Impurity 7 (CAS CATO-C4X-15477), a pharmacopoeial impurity reference standard (molecular formula C19H28O8, MW 384.42 g/mol) used for the identification and quantification of trace impurities in APIs.
The molecular framework of Artesunate Impurity 7 (C19H28O8) 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 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), Artesunate Impurity 7 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 | C19H28O8 |
| Molecular Weight | 384.42 g/mol |
| Appearance | Off-white to pale yellow crystalline powder |
| Purity | ≥95% |
| Storage | Store at 2-8°C, 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 |