Dutasteride EP Impurity E (Dutasteride 17-alpha-epimer) CAS 2102935-76-0
| CAS No. | 2102935-76-0 |
| Molecular Formula | C27H30F6N2O2 |
| Molecular Weight | 528.53 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a process- or degradation-related impurity, Dutasteride EP Impurity E (Dutasteride 17-alpha-epimer) (CAS 2102935-76-0, C27H30F6N2O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution, Dutasteride EP Impurity E (Dutasteride 17-alpha-epimer) is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 528.53 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.
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.
The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.
Physical & Chemical Properties
| Molecular Formula | C27H30F6N2O2 |
| Molecular Weight | 528.53 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) | 11.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1997 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 2 |
Related Dutasteride Standards
- Dutasteride Impurity N88 (CAS 164656-21-7)
- Dutasteride EP Impurity E(Relative stereochemistry) (CAS 1796930-46-5)
- 5beta-Dutasteride (CAS 957229-52-6)
- Dutasteride Impurity 14 (CAS CATO-C4X-110314)
- Dutasteride (CAS 164656-23-9)
- Dutasteride EP Impurity I (CAS 3088800-46-5)
- Dutasteride EP Impurity G (CAS 1430804-85-5)
- Dutasteride Impurity 5 (CAS 164656-22-8)
Recommended Standards
- Mal-amido-PEG2-C2-amido-Ph-C2-CO-AZD (CAS 1037589-69-7)
- PHYSALIN L (CAS 113146-74-0)
- (3aR,8aR)-6-Hydroxy-2,2-dimethyl-4,4,8,8-tetraphenyltetrahydro-[1,3]dioxolo[4,5-e][1,3,2]dioxaphosphepine 6-oxide (CAS 945763-92-8)
- Glaucin B (CAS 115458-73-6)
- Brivaracetam Impurity 11 (CAS CATO-C4X-200711)
- Fluticasone Impurity 76 (CAS CATO-C4X-165076)
- Cloperastine Impurity 4 HCl (CAS CATO-C4X-15954)
- 4-Amino-N,1-dimethyl-5-imidazolecarboxamide-d3 (CAS 1189466-51-0)
- tert-Butyl ((6-bromopyridin-2-yl)methyl)(methyl)carbamate (CAS 1093878-97-7)
- 1,3-Diethyl 2-({2-[4-(furan-2-carbonyloxy)phenyl]pyrimidin-4-yl}methylidene)propanedioate (CAS 477870-98-7)
- 2,3-Dichloro-6-(difluoromethoxy)benzyl bromide (CAS 1803789-66-3)
- (3-(1-Propyl-1H-pyrazol-5-yl)-1,2,4-oxadiazol-5-yl)methanamine (CAS 1710302-25-2)
- 6-Bromoquinoline-3-carboxylic Acid (CAS 798545-30-9)
- Calcineurin Autoinhibitory Peptide (CAS 148067-21-4)
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