Amphotericin Impurity 9 CAS CATO-C4X-18449
| CAS No. | CATO-C4X-18449 |
| Molecular Formula | C47H75NO18 |
| Molecular Weight | 942.09 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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.
As a process- or degradation-related impurity, Amphotericin Impurity 9 (CAS CATO-C4X-18449, C47H75NO18) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Structurally, Amphotericin Impurity 9 (C47H75NO18) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 11.0, corresponding to approximately 11 ring(s) or double-bond equivalent(s). With a molecular weight of 942.09 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.
Physical & Chemical Properties
| Molecular Formula | C47H75NO18 |
| Molecular Weight | 942.09 g/mol |
| Purity | >75% |
| Storage | Store at room temperature, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 11.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Nitrogen Atoms | 1 |
Related Amphotericin Standards
- Amphotericin Methyl Ester-d3 (CAS CATO-CCAD303860)
- Amphotericin B Impurity 21 (CAS CATO-C4X-184421)
- Amphotericin B Impurity 1(Amphotericin B Methyl Ester) (CAS 36148-89-7)
- Amphotericin B ChP Impurity D((13S)-13-O-Methylamphotericin) (CAS 944242-31-3)
- Amphotericin B Impurity 25 (CAS CATO-C4X-184425)
- Amphotericin B Impurity 26 (CAS CATO-C4X-184426)
- Amphotericin B EP Impurity B (CAS 136135-57-4)
- Amphotericin B ChP Impurity E (CAS CATO-C4X-184414)
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