| CAS No. | CATO-C4X-106117 |
| Molecular Formula | C40H50N8O8 |
| Molecular Weight | 770.87 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 Istradefylline Impurity 17 (Mixture of Diastereomers).
CATO supplies Istradefylline Impurity 17 (Mixture of Diastereomers) (CAS CATO-C4X-106117), a pharmacopoeial impurity reference standard (molecular formula C40H50N8O8, MW 770.87 g/mol) used for the identification and quantification of trace impurities in APIs.
Structurally, Istradefylline Impurity 17 (Mixture of Diastereomers) (C40H50N8O8) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 20.0, corresponding to approximately 20 ring(s) or double-bond equivalent(s). With a molecular weight of 770.87 g/mol, it falls into the high-molecular-weight range. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.
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), Istradefylline Impurity 17 (Mixture of Diastereomers) 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 | C40H50N8O8 |
| Molecular Weight | 770.87 g/mol |
| Purity | >95% |
| Storage | Store in a cool place (≤25°C), protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening |
| Degree of Unsaturation (DBE) | 20.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Nitrogen Atoms | 8 |