Amphotericin B EP Impurity B CAS 136135-57-4
| CAS No. | 136135-57-4 |
| Molecular Formula | C48H75NO17 |
| Molecular Weight | 938.11 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.
As a process- or degradation-related impurity, Amphotericin B EP Impurity B (CAS 136135-57-4, C48H75NO17) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Amphotericin B EP Impurity B (C48H75NO17) 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 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).
As a certified reference material (CRM), Amphotericin B EP Impurity B meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.
Physical & Chemical Properties
| Molecular Formula | C48H75NO17 |
| Molecular Weight | 938.11 g/mol |
| Purity | >85% |
| 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) | 12.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1995 |
| Nitrogen Atoms | 1 |
Related Amphotericin Standards
- 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 Impurity 21 (CAS CATO-C4X-184421)
- Amphotericin Methyl Ester-d3 (CAS CATO-CCAD303860)
- Amphotericin Impurity 9 (CAS CATO-C4X-18449)
- Amphotericin B-13C6 (CAS 1397-89-3 (non-labelled))
Recommended Standards
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