Amikacin EP Impurity E CAS 50866-72-3
| CAS No. | 50866-72-3 |
| Molecular Formula | C22H43N5O13 |
| Molecular Weight | 585.60 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Amikacin EP Impurity E.
Amikacin EP Impurity E (CAS 50866-72-3) is a certified pharmaceutical impurity reference standard with the molecular formula C22H43N5O13 and a molecular weight of 585.60 g/mol.
Structurally, Amikacin EP Impurity E (C22H43N5O13) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 4.0, corresponding to approximately 4 ring(s) or double-bond equivalent(s). With a molecular weight of 585.60 g/mol, it falls into the moderately-high-molecular-weight range. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.
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 | C22H43N5O13 |
| Molecular Weight | 585.60 g/mol |
| Appearance | Off-white to pale yellow crystalline powder |
| Purity | >95% |
| 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) | 4.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1971 |
| Nitrogen Atoms | 5 |
Related Amikacin Standards
- Amikacin EP Impurity A (CAS 50725-24-1)
- Amikacin EP Impurity C (CAS 50725-25-2)
- Amikacin (CAS 37517-28-5)
- Amikacin EP Impurity H (CAS 48237-20-3)
- Amikacin Impurity 20 (CAS CATO-C4X-197720)
- Amikacin impurity 30 (CAS CATO-C4X-197730)
- Amikacin Impurity B (CAS 927821-99-6)
- Amikacin impurity 28 (CAS 197909-66-3)
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- Trimebutine EP Impurity B/Trimethoprim EP Impurity J (CAS 118-41-2)
- 2-(4-Aminocyclohexyl)acetic acid (CAS 1197-54-2)
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