Ethinylestradiol EP Impurity J CAS 15071-66-6
| CAS No. | 15071-66-6 |
| Molecular Formula | C21H26O2 |
| Molecular Weight | 310.43 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 Ethinylestradiol EP Impurity J.
Ethinylestradiol EP Impurity J (CAS 15071-66-6) is a certified pharmaceutical impurity reference standard with the molecular formula C21H26O2 and a molecular weight of 310.43 g/mol.
The molecular framework of Ethinylestradiol EP Impurity J (C21H26O2) is characterized by a steroid core, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
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), Ethinylestradiol EP Impurity J 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 | C21H26O2 |
| Molecular Weight | 310.43 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light |
| 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.) | 1961 |
Related Ethinylestradiol Standards
- Ethinylestradiol 1-Hydroxy 4-Methyl Impurity (CAS 1034298-00-4)
- Ethinylestradiol EP Impurity K (CAS 155683-61-7)
- Ethinylestradiol EP Impurity M (CAS 3240-39-9)
- Ethinylestradiol EP Impurity G (CAS 38002-18-5)
- Ethinylestradiol EP Impurity H (CAS 1350468-76-6)
- Ethinylestradiol EP Impurity F (CAS 56324-28-8)
- Ethinylestradiol EP Impurity E (6-alpha-Hydroxy Ethynylestradiol) (CAS 27521-34-2)
- Ethinylestradiol 2-Hydroxy Impurity (CAS 50394-89-3)
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- 3-Amino-3-(4-fluorophenyl)cyclobutan-1-ol (CAS 1353636-62-0)
- Semaglutide impurity 28 (CAS CATO-C4X-222628)
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