Obeticholic Acid Impurity 12 CAS 1885104-64-2
| CAS No. | 1885104-64-2 |
| Molecular Formula | C26H42O4 |
| Molecular Weight | 418.61 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Obeticholic Acid Impurity 12 (CAS 1885104-64-2) is a certified pharmaceutical impurity reference standard with the molecular formula C26H42O4 and a molecular weight of 418.61 g/mol.
Obeticholic Acid Impurity 12 (C26H42O4) contains a steroid core, 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 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.
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 | C26H42O4 |
| Molecular Weight | 418.61 g/mol |
| Appearance | Off-white to pale yellow crystalline powder |
| Purity | 97%+ |
| Storage | Store at room temperature, 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) | 6.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1995 |
Related Obeticholic Standards
- Obeticholic Acid Impurity 33 (CAS 1908444-27-8)
- Obeticholic Acid Impurity 34 (CAS CATO-C4X-115334)
- Obeticholic Acid Impurity 4 (CAS 1947343-07-8)
- Obeticholic Acid Impurity 5 (CAS 915038-26-5)
- Obeticholic Acid Impurity 52 (CAS CATO-C4X-115352)
- Obeticholic Acid Impurity 6 (CAS 915038-25-4)
- Obeticholic Acid (CAS 459789-99-2)
- Obeticholic Acid Impurity 1 (CAS 865244-30-0)
Recommended Standards
- Ursodeoxycholic Acid Impurity 1 (CAS 4057-84-5)
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- Cefoperazone Impurity 50 (CAS CATO-C4X-114950)
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- Benzyl (4-aminobutan-2-yl)carbamate hydrochloride (CAS 1965309-06-1)
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