Misoprostol EP Impurity C CAS 58682-86-3
| CAS No. | 58682-86-3 |
| Molecular Formula | C22H36O4 |
| Molecular Weight | 364.53 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Misoprostol EP Impurity C is closely related to a steroid core, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
As a process- or degradation-related impurity, Misoprostol EP Impurity C (CAS 58682-86-3, C22H36O4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Misoprostol EP Impurity C (C22H36O4) is characterized by a steroid core, 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 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.
As a certified reference material (CRM), Misoprostol EP Impurity C 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.
Physical & Chemical Properties
| Molecular Formula | C22H36O4 |
| Molecular Weight | 364.53 g/mol |
| Appearance | Off-white to pale yellow crystalline powder |
| 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 |
| Degree of Unsaturation (DBE) | 5.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1973 |
Related Misoprostol Standards
- Misoprostol EP Impurity D (Mixture of E/Z-Isomers) (CAS 1331639-92-9)
- Misoprostol EP Impurity D (Mixture of Enantiomers) (CAS 1788085-79-9)
- Misoprostol Acid (CAS 112137-89-0)
- Misoprostol Acid (Mixture of Diastereomers) (CAS 66792-31-2)
- Misoprostol Impurity 7 (CAS CATO-C4X-14597)
- Misoprostol-d5 (CAS 1337917-44-8)
- Misoprostol EP Impurity A (mixture of isomers) (CAS 1788085-78-8)
- Misoprostol Impurity 1 (CAS CATO-C4X-14591)
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