Spiramycin EP Impurity E CAS 177584-14-4
| CAS No. | 177584-14-4 |
| Molecular Formula | C43H76N2O13 |
| Molecular Weight | 829.07 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 829.07 g/mol gives Spiramycin EP Impurity E distinctive chromatographic separation conditions and mass-spectrometry parameter settings.
As a process- or degradation-related impurity, Spiramycin EP Impurity E (CAS 177584-14-4, C43H76N2O13) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Spiramycin EP Impurity E (C43H76N2O13) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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 | C43H76N2O13 |
| Molecular Weight | 829.07 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) | 7.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 2007 |
| Nitrogen Atoms | 2 |
Related Spiramycin Standards
- Spiramycin EP Impurity E (CAS CATO-C4X-23255)
- Spiramycin (CAS 8025-81-8)
- Spiramycin I (CAS 24916-50-5)
- Spiramycin EP Impurity B (CAS 249930-66-3)
- Spiramycin EP Impurity D (CAS 87708-39-2)
- Spiramycin EP Impurity D (CAS CATO-C4X-23254)
- Spiramycin I (CAS CATO-C4X-2325)
- Spiramycin EP Impurity B (CAS CATO-C4X-23252)
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