Leuprorelin Impurity 55 CAS CATO-C4X-182255
| CAS No. | CATO-C4X-182255 |
| Molecular Formula | C65H92N16O16 |
| Molecular Weight | 1353.52 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Leuprorelin Impurity 55 (CAS CATO-C4X-182255) is a certified pharmaceutical impurity reference standard with the molecular formula C65H92N16O16 and a molecular weight of 1353.52 g/mol.
Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, Leuprorelin Impurity 55 is typically pale yellow to yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 1353.52 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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 | C65H92N16O16 |
| Molecular Weight | 1353.52 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) | 28.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Nitrogen Atoms | 16 |
Related Leuprorelin Standards
- Leuprorelin Impurity 56 (CAS CATO-C4X-182256)
- Leuprorelin Impurity 57 (CAS CATO-C4X-182257)
- Leuprorelin Impurity 58 (CAS CATO-C4X-182258)
- Leuprorelin Impurity 64 (CAS CATO-C4X-182264)
- Leuprorelin Impurity 21 (CAS 134053-51-3)
- Leuprorelin Impurity 53 (CAS CATO-C4X-182253)
- Leuprorelin Impurity 54 (CAS CATO-C4X-182254)
- Leuprorelin Impurity 44 (CAS CATO-C4X-182244)
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