Roxithromycin EP Impurity E CAS 1460313-66-9
| CAS No. | 1460313-66-9 |
| Molecular Formula | C40H74N2O15 |
| Molecular Weight | 823.02 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Compared with other compounds in its class, the molecular weight of 823.02 g/mol gives Roxithromycin EP Impurity E distinctive chromatographic separation conditions and mass-spectrometry parameter settings.
Roxithromycin EP Impurity E (CAS 1460313-66-9) is a certified pharmaceutical impurity reference standard with the molecular formula C40H74N2O15 and a molecular weight of 823.02 g/mol.
The molecular framework of Roxithromycin EP Impurity E (C40H74N2O15) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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.
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 | C40H74N2O15 |
| Molecular Weight | 823.02 g/mol |
| Purity | >90% |
| 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) | 5.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1992 |
| Nitrogen Atoms | 2 |
Related Roxithromycin Standards
- Roxithromycin EP Impurity F (CAS 118267-18-8)
- Roxithromycin EP Impurity H (CAS 425365-65-7)
- Roxithromycin EP Impurity D (CAS 134931-00-3)
- Roxithromycin (CAS 80214-83-1)
- Roxithromycin EP Impurity J (CAS 134834-12-1)
- Roxithromycin Impurity 24 (CAS CATO-C4X-130324)
- Roxithromycin-d7 (CAS CATO-C4X-130322)
- Roxithromycin-d7 (CAS CATO-CCAD300664)
Recommended Standards
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