| CAS No. | CATO-C4X-149747 |
| Molecular Formula | 2*C34H34Cl2N8O4 |
| Molecular Weight | N/A |
| 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 Itraconazole Impurity 47.
CATO supplies Itraconazole Impurity 47 (CAS CATO-C4X-149747), a pharmacopoeial impurity reference standard (molecular formula C34H34Cl2N8O4, MW 689.60 g/mol) used for the identification and quantification of trace impurities in APIs.
Structurally, Itraconazole Impurity 47 (C34H34Cl2N8O4) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 21.0, corresponding to approximately 21 ring(s) or double-bond equivalent(s). With a molecular weight of 689.60 g/mol, it falls into the high-molecular-weight range. 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.
CATO manufactures Itraconazole Impurity 47 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.
| Molecular Formula | 2*C34H34Cl2N8O4 |
| Molecular Weight | 689.60 g/mol |
| Purity | 97%+ |
| 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; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 21.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 8 |