Dienogest Impurity 17 CAS 83196-58-1
| CAS No. | 83196-58-1 |
| Molecular Formula | C22H31NO3 |
| Molecular Weight | 357.49 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Compared with other compounds in its class, the molecular weight of 357.49 g/mol gives Dienogest Impurity 17 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.
As a process- or degradation-related impurity, Dienogest Impurity 17 (CAS 83196-58-1, C22H31NO3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Dienogest Impurity 17 (C22H31NO3) contains a steroid core, an amide group, a hydroxyl group, an ether linkage. Its high carbon-to-hydrogen ratio confers good lipid solubility, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.
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 | C22H31NO3 |
| Molecular Weight | 357.49 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) | 8.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1980 |
| Nitrogen Atoms | 1 |
Related Dienogest Standards
- Dienogest EP Impurity E (CAS 102193-41-9)
- 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)
Recommended Standards
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- Tamoxifen EP Impurity F (CAS 31750-48-8)
- Trifluridine Impurity 7 (CAS CATO-C4X-20567)
- Metoclopramide impurity 81 (CAS CATO-C4X-141581)
- Linagliptin Impurity 110 (CAS CATO-C4X-1101110)
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- Methyl 4-(5-nitropyridin-2-yl)benzoate (CAS 223127-51-3)
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- N-(3-Amino-4-chlorophenyl)-2-furamide (CAS 926265-06-7)
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- Ethyl 1-methyl-7-oxo-4,7-dihydro-1H-pyrazolo[4,3-b]pyridine-6-carboxylate (CAS 59376-44-2)
- Prolactin-Releasing Peptide (12-31) (human) (CAS 235433-36-0)
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