Calcifediol Impurity 12 CAS 23357-18-8
| CAS No. | 23357-18-8 |
| Molecular Formula | C27H44O2 |
| Molecular Weight | 400.64 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.
As a process- or degradation-related impurity, Calcifediol Impurity 12 (CAS 23357-18-8, C27H44O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Structurally, Calcifediol Impurity 12 (C27H44O2) contains a steroid core, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 6.0, corresponding to approximately 6 ring(s) or double-bond equivalent(s). With a molecular weight of 400.64 g/mol, it falls into the moderately-high-molecular-weight range. 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.
Physical & Chemical Properties
| Molecular Formula | C27H44O2 |
| Molecular Weight | 400.64 g/mol |
| Appearance | Off-white to pale yellow crystalline powder |
| Purity | >85% |
| Storage | Store at room temperature, 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) | 6.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1963 |
Related Calcifediol Standards
- Calcifediol EP Impurity C (CAS 39932-44-0)
- Calcifediol Impurity 32 (CAS 2963746-77-0)
- Calcifediol Impurity 1 (CAS 36149-00-5)
- Calcifediol Monohydrate EP Impurity A (CAS 61585-29-3)
- Calcifediol Impurity 11 (CAS CATO-C4X-189211)
- Calcifediol EP Impurity B (CAS 22145-68-2)
- Calcifediol Impurity 14 (CAS CATO-C4X-189214)
- Calcifediol EP Impurity D (CAS 1233749-00-2)
Recommended Standards
- 7,8-Epoxy-vitamin D3 (CAS 89231-90-3)
- Calcifediol Impurity 5 (CAS 69556-15-6)
- Cholecalciferol Impurity 32 (CAS 89231-92-5)
- Calcifediol (CAS 19356-17-3)
- Sulpiride EP Impurity E (CAS 52395-25-2)
- Ceftiofur Impurity 7 (CAS CATO-C4X-15817)
- Tofacitinib Impurity 45 (CAS CATO-C4X-107945)
- n'-(2-Chloroacetyl)-4-ethyl-5-methylthiophene-2-carbohydrazide (CAS 794582-33-5)
- 1-Bromo-2-[(4-fluorobutyl)sulfanyl]benzene (CAS 885267-11-8)
- N,N'-(Pyrimidine-2,5-diyl)dibenzamide (CAS 139522-11-5)
- 6,6-Dimethyl-1,4-dioxaspiro[4.5]decan-8-one (CAS 131206-75-2)
- (±)-1-Phenylethan-1,2,2,2-d4-ol (CAS 90162-44-0)
- 7'-(Trifluoromethyl)spiro[cyclopropane-1,3'-indoline] (CAS 1516693-07-4)
- Peptide Impurity 64 (CAS CATO-CPTD788964)
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