Leuprorelin Impurity 54 CAS CATO-C4X-182254
| CAS No. | CATO-C4X-182254 |
| Molecular Formula | C62H88N16O14 |
| Molecular Weight | 1281.46 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a process- or degradation-related impurity, Leuprorelin Impurity 54 (CAS CATO-C4X-182254, C62H88N16O14) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Based on its molecular formula C62H88N16O14, Leuprorelin Impurity 54 contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 1281.46 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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 | C62H88N16O14 |
| Molecular Weight | 1281.46 g/mol |
| Purity | >95% |
| Storage | Store in a cool place (≤25°C), protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening |
| Degree of Unsaturation (DBE) | 27.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Nitrogen Atoms | 16 |
Related Leuprorelin Standards
- Leuprorelin Impurity 53 (CAS CATO-C4X-182253)
- Leuprorelin Impurity 44 (CAS CATO-C4X-182244)
- Leuprorelin impurity 36 (CAS 1926163-25-8)
- Leuprorelin Impurity 50 (CAS CATO-C4X-182250)
- Leuprorelin Impurity 21 (CAS 134053-51-3)
- Leuprorelin Impurity 64 (CAS CATO-C4X-182264)
- Leuprorelin Impurity 61 (CAS CATO-C4X-182261)
- Leuprorelin Impurity 47 (CAS CATO-C4X-182247)
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