Dienogest EP Impurity E CAS 102193-41-9
| CAS No. | 102193-41-9 |
| Molecular Formula | C22H31NO3 |
| Molecular Weight | 357.49 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.
CATO supplies Dienogest EP Impurity E (CAS 102193-41-9), a pharmacopoeial impurity reference standard (molecular formula C22H31NO3, MW 357.49 g/mol) used for the identification and quantification of trace impurities in APIs.
The molecular framework of Dienogest EP Impurity E (C22H31NO3) is characterized by a steroid core, an amide group, 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.
Physical & Chemical Properties
| Molecular Formula | C22H31NO3 |
| Molecular Weight | 357.49 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| Purity | >95% |
| 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) | 8.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1986 |
| Nitrogen Atoms | 1 |
Related Dienogest Standards
- Dienogest Impurity 17 (CAS 83196-58-1)
- Dienogest EP Impurity D (CAS 190662-30-7)
- Dienogest EP Impurity K (CAS 106111-43-7)
- Dienogest Impurity 15 (CAS CATO-C4X-229515)
- Dienogest Impurity 20 (CAS 34686-78-9)
- Dienogest EP Impurity A (CAS 86153-39-1)
- Dienogest EP Impurity J (CAS 24284-84-2)
- Dienogest EP Impurity M (CAS 98149-13-4)
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Why CATO?
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