| CAS No. | CATO-C4X-22124 |
| Molecular Formula | C60H86N16O13 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
CATO manufactures Buserelin EP Impurity D 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.
CATO supplies Buserelin EP Impurity D (CAS CATO-C4X-22124), a pharmacopoeial impurity reference standard (molecular formula C60H86N16O13C2H4O2, MW 1299.50 g/mol) used for the identification and quantification of trace impurities in APIs.
Structurally, Buserelin EP Impurity D (C60H86N16O13C2H4O2) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 26.0, corresponding to approximately 26 ring(s) or double-bond equivalent(s). With a molecular weight of 1299.50 g/mol, it falls into the high-molecular-weight range. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
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.
| Molecular Formula | C60H86N16O13 C2H4O2 |
| Molecular Weight | 1299.50 g/mol |
| Purity | >80% |
| 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) | 26.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Nitrogen Atoms | 16 |