Estradiol impurity 48 CAS 95960-05-7
| CAS No. | 95960-05-7 |
| Molecular Formula | C25H34O3 |
| Molecular Weight | 382.54 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a process- or degradation-related impurity, Estradiol impurity 48 (CAS 95960-05-7, C25H34O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Based on its molecular formula C25H34O3, Estradiol impurity 48 contains a steroid core, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 382.54 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).
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), Estradiol impurity 48 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 | C25H34O3 |
| Molecular Weight | 382.54 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 9.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1984 |
Related Estradiol Standards
- Estradiol Hexahydrobenzoate (CAS 15140-27-9)
- 17-Beta-Estradiol 3,17-Dipropionate (CAS 113-38-2)
- Estradiol Enanthate (CAS 4956-37-0)
- 17β-Estradiol-16,16,17-d3 3-Benzoate (CAS 1192354-74-7)
- Estradiol Benzoate EP Impurity D (CAS 983-30-2)
- Estradiol Benzoate EP Impurity E (CAS 6045-53-0)
- Estradiol benzoate (CAS 50-50-0)
- Estradiol Benzoate EP Impurity B (CAS CATO-C4X-35511)
Recommended Standards
- N,N-Dibutyl-4-[4-(tert-butyl)benzoyl]-1H-pyrrole-2-carboxamide (CAS 478078-46-5)
- Norethisterone Acetate EP Impurity H (CAS 2417092-17-0)
- Anhydroepiophiobolin A (CAS 90411-20-4)
- Maropitant Impurity 13 (CAS 155681-48-4)
- Josamycin EP Impurity F (CAS 22875-15-6)
- Melitracen Impurity 5 (CAS 111-18-2)
- Solifenacin EP Impurity G Succinate (CAS 862207-70-3)
- 5-Amino-2-(trifluoromethoxy)benzoic acid (CAS 307989-56-6)
- (3R,4R)-4-Amino-1-hydroxy-2,2,5,5-tetramethylpyrrolidine-3-carboxylic acid (CAS 96938-41-9)
- Atogepant Impurity N17 (CAS 1455358-16-3)
- Phe-Phe-D-Leu-D-Lys-4-aminohexahydropyridine-4-carboxylic acid (CAS CATO-CPTD788784)
- (3-(Benzo[d][1,3]dioxol-5-yl)isoxazol-5-yl)methanamine (CAS 885273-58-5)
- 2-Methyl-3-(4,4,5,5-tetramethyl-1,3,2-dioxaborolan-2-yl)-2H-indazole (CAS 1632159-69-3)
- (Cys2)-Neuropeptide Y-8-aminooctanoyl-(D-Cys27)-Neuropeptide Y (25-32) (H-3298.0500) (CAS 128806-04-2)
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