| CAS No. | 328-93-8 |
| Molecular Formula | C8H5F6N |
| Molecular Weight | 229.12 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Compared with other compounds in its class, the molecular weight of 229.12 g/mol gives Dutasteride Impurity 4 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.
CATO supplies Dutasteride Impurity 4 (CAS 328-93-8), a pharmacopoeial impurity reference standard (molecular formula C8H5F6N, MW 229.12 g/mol) used for the identification and quantification of trace impurities in APIs.
The molecular framework of Dutasteride Impurity 4 (C8H5F6N) is characterized by a nitrogen-containing heterocyclic scaffold, a nitrile group, fluorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
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 Dutasteride Impurity 4 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 | C8H5F6N |
| Molecular Weight | 229.12 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor, faint amine-like odor, low volatility) |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 4.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1957 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 1 |