Dutasteride EP Impurity F CAS CATO-C4X-11036
| CAS No. | CATO-C4X-11036 |
| Molecular Formula | C27H31ClF6N2O2 |
| Molecular Weight | 564.99 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Dutasteride EP Impurity F.
CATO supplies Dutasteride EP Impurity F (CAS CATO-C4X-11036), a pharmacopoeial impurity reference standard (molecular formula C27H31ClF6N2O2, MW 564.99 g/mol) used for the identification and quantification of trace impurities in APIs.
Structurally, Dutasteride EP Impurity F (C27H31ClF6N2O2) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 10.0, corresponding to approximately 10 ring(s) or double-bond equivalent(s). With a molecular weight of 564.99 g/mol, it falls into the moderately-high-molecular-weight range. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.
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), Dutasteride EP Impurity F 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.
Physical & Chemical Properties
| Molecular Formula | C27H31ClF6N2O2 |
| Molecular Weight | 564.99 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| 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) | 10.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | F/Cl-containing |
| Nitrogen Atoms | 2 |
Related Dutasteride Standards
- Dutasteride Impurity 26 (CAS CATO-C4X-110326)
- Dutasteride Impurity 23 (CAS CATO-C4X-110323)
- Dutasteride Impurity 32 (CAS CATO-C4X-110332)
- Dutasteride-13C6 (CAS 1217685-27-2)
- Dutasteride-d3Discontinued, see D735004 (CAS 1131341-46-2)
- Dutasteride Impurity 5 (CAS 164656-22-8)
- Dutasteride Impurity N88 (CAS 164656-21-7)
- Dutasteride EP Impurity E(Relative stereochemistry) (CAS 1796930-46-5)
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