Lubiprostone Impurity 36 CAS 321457-71-0
| CAS No. | 321457-71-0 |
| Molecular Formula | C20H32F2O4 |
| Molecular Weight | 374.46 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a certified reference material (CRM), Lubiprostone Impurity 36 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.
Lubiprostone Impurity 36 (CAS 321457-71-0) is a certified pharmaceutical impurity reference standard with the molecular formula C20H32F2O4 and a molecular weight of 374.46 g/mol.
The molecular framework of Lubiprostone Impurity 36 (C20H32F2O4) is characterized by a steroid core, a hydroxyl group, an ether linkage, fluorine substitution. 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 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.
Physical & Chemical Properties
| Molecular Formula | C20H32F2O4 |
| Molecular Weight | 374.46 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | 97%+ |
| Storage | Store at room temperature, keep sealed and dry |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 4.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 2025 |
| Halogen Content | F-containing |
Related Lubiprostone Standards
- Lubiprostone Impurity 37 (CAS CATO-C4X-113637)
- Lubiprostone impurity 4 (CAS 2196182-47-3)
- Lubiprostone Impurity 42 (CAS CATO-C4X-113642)
- Lubiprostone Impurity 44 (CAS CATO-C4X-113644)
- Lubiprostone Impurity 34 (CAS CATO-C4X-113634)
- Lubiprostone Impurity 29 (CAS CATO-C4X-113629)
- Lubiprostone Impurity 10 (CAS 136790-72-2)
- Lubiprostone Impurity 17 (CAS 136790-73-3)
Recommended Standards
- Oxazole, 2,2′-(2,5-thiophenediyl)bis[4,5-dihydro-4-phenyl-, (4R,4′R)- (CAS 420783-04-6)
- 16a-Methyl Prednisolone (CAS 10417-63-7)
- N-(4-acetamidophenyl)-2-((1-cyclohexyl-1H-tetrazol-5-yl)thio)acetamide (CAS 821807-33-4)
- 2,2,4,5-Tetraphenyl-2,3-dihydrofuran (CAS 1056-32-2)
- Indometacin Impurity 29 (CAS CATO-C4X-147029)
- Mosapride Impurity 23 (CAS CATO-C4X-104423)
- Cholic Acid Impurity 81 (CAS CATO-C4X-116081)
- 6-chloro-3,3-dimethyl-1,2-dihydropyrrolo[2,3-b]pyridine;hydrochloride (CAS 1946021-29-9)
- Paroxetine Impurity 15 (CAS 69393-72-2)
- 2-(Difluoromethyl)-7-methylbenzo[d]oxazole (CAS 1806319-99-2)
- 3-Methyl-5-oxo-5,8-dihydro[1,2,4]triazolo[4,3-a]pyrimidine-6-carboxylic acid hydrate (CAS 1396784-46-5)
- Chlorpheniramine Impurity 40 (CAS CATO-C4X-118840)
- 2-Bromo-4-(difluoromethyl)-6-fluoropyridine (CAS 1806011-22-2)
- Biotinyl-Neuropeptide Y (human, rat) trifluoroacetate salt (CAS 213779-13-6)
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