Amikacin EP Impurity A CAS 50725-24-1
| CAS No. | 50725-24-1 |
| Molecular Formula | C22H43N5O13 |
| Molecular Weight | 585.60 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The molecular framework of Amikacin EP Impurity A (C22H43N5O13) 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 process- or degradation-related impurity, Amikacin EP Impurity A (CAS 50725-24-1, C22H43N5O13) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
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 | >85% |
| 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 E (CAS 50866-72-3)
- 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)
Recommended Standards
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- Decitabine Impurity 27（Mixture of Diastereoisomer） (CAS CATO-C4X-113727)
- Etravirine Impurity 2 (CAS 1225383-64-1)
- Cinacalcet Impurity 22 (CAS 21172-43-0)
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- Rivaroxaban Impurity 182 (CAS CATO-C4X-1090182)
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- 1-[2-fluoro-5-(trifluoromethyl)phenyl]guanidine hydrochloride (CAS 1803587-42-9)
- 1-(4-Bromophenyl)-3-(dibenzylamino)pyrrolidine-2,5-dione (CAS 1024631-74-0)
- Glucagon (19-29) (human, rat, porcine) (CAS 64790-15-4)
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