| CAS No. | 1648593-70-7 |
| Molecular Formula | C46H55F6N3O4 |
| Molecular Weight | 827.94 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Compared with other compounds in its class, the molecular weight of 827.94 g/mol gives Dutasteride EP Impurity I distinctive chromatographic separation conditions and mass-spectrometry parameter settings.
Dutasteride EP Impurity I (CAS 1648593-70-7) is a certified pharmaceutical impurity reference standard with the molecular formula C46H55F6N3O4 and a molecular weight of 827.94 g/mol.
Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution, Dutasteride EP Impurity I is typically pale yellow to yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 827.94 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.
As a certified reference material (CRM), Dutasteride EP Impurity I 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 | C46H55F6N3O4 |
| Molecular Weight | 827.94 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; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 18.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1993 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 3 |