Estradiol Valerate EP Impurity I CAS CATO-C4X-28427
| CAS No. | CATO-C4X-28427 |
| Molecular Formula | C49H66O5 |
| Molecular Weight | 735.05 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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.
Estradiol Valerate EP Impurity I (CAS CATO-C4X-28427) is a certified pharmaceutical impurity reference standard with the molecular formula C49H66O5 and a molecular weight of 735.05 g/mol.
Structurally, Estradiol Valerate EP Impurity I (C49H66O5) contains a carboxylic acid group, a hydroxyl group, an ether linkage, a polycyclic aromatic system. The molecule exhibits a degree of unsaturation (DBE) of 17.0, corresponding to approximately 17 ring(s) or double-bond equivalent(s). With a molecular weight of 735.05 g/mol, it falls into the high-molecular-weight range. 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.
Physical & Chemical Properties
| Molecular Formula | C49H66O5 |
| Molecular Weight | 735.05 g/mol |
| Purity | >95% |
| Storage | Store at room temperature, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 17.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
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- Loratadine Impurity 28 (CAS 3964-81-6)
- 1-((3-Bromothiophen-2-yl)methyl)-1h-pyrazol-3-amine (CAS 1250547-14-8)
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