| CAS No. | 5817-39-0 |
| Molecular Formula | C15H12I3NO4 |
| Molecular Weight | 650.97 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Levothyroxine EP Impurity K (CAS 5817-39-0) is a certified pharmaceutical impurity reference standard with the molecular formula C15H12I3NO4 and a molecular weight of 650.97 g/mol.
Owing to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, iodine substitution, Levothyroxine EP Impurity K is typically pale yellow to yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 650.97 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
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.
CATO manufactures Levothyroxine EP Impurity K under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.
| Molecular Formula | C15H12I3NO4 |
| Molecular Weight | 650.97 g/mol |
| Purity | >90% |
| Storage | Store at room temperature, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 9.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1958 |
| Halogen Content | I-containing |
| Nitrogen Atoms | 1 |