BB-K 6 Disulfate Salt (Amikacin EP Impurity E Disulfate) CAS 50866-72-3(Free Base)
| CAS No. | 50866-72-3(Free Base) |
| Molecular Formula | C22H43N5O13 |
| Molecular Weight | N/A |
| 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, BB-K 6 Disulfate Salt (Amikacin EP Impurity E Disulfate) (CAS 50866-72-3(Free Base), C22H43N5O13H2O4S) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of BB-K 6 Disulfate Salt (Amikacin EP Impurity E Disulfate) (C22H43N5O13H2O4S) is characterized by an amide group, a sulfone group, a carboxylic acid 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. 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.
Physical & Chemical Properties
| Molecular Formula | C22H43N5O13 2*H2O4S |
| Molecular Weight | 683.68 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) | 3.0 |
| UV Absorption | UV-absorbing |
| Nitrogen Atoms | 5 |
| Sulfur Atoms | 1 |
Recommended Standards
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- Dutasteride Impurity 4 (CAS 328-93-8)
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