Argatroban Impurity 48 CAS CATO-C4X-100748
| CAS No. | CATO-C4X-100748 |
| Molecular Formula | C15H30N6O5 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a process- or degradation-related impurity, Argatroban Impurity 48 (CAS CATO-C4X-100748, C15H30N6O5HCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Structurally, Argatroban Impurity 48 (C15H30N6O5HCl) contains an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 3.0, corresponding to approximately 3 ring(s) or double-bond equivalent(s). With a molecular weight of 410.90 g/mol, it falls into the moderately-high-molecular-weight range. 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).
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 | C15H30N6O5 HCl |
| Molecular Weight | 410.90 g/mol |
| Appearance | White to pale yellow crystalline powder. (slight halide-like odor) |
| Purity | 97%+ |
| 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; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 3.0 |
| UV Absorption | UV-absorbing |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 6 |
Related Argatroban Standards
- Argatroban Impurity 78 (CAS 121785-71-5)
- Argatroban Impurity 79 (CAS 121785-72-6)
- Argatroban Impurity 80 (CAS 1260981-49-4)
- Argatroban Impurity 23 (CAS 1356847-56-7)
- Argatroban (CAS 141396-28-3)
- Argatroban Impurity 10 (CAS 1448301-07-2)
- Argatroban Impurity 109 (CAS 1515961-07-5)
- Argatroban Impurity 95 (CAS 153886-68-1)
Recommended Standards
- Melitracen Impurity 12 (CAS CATO-C4X-120212)
- Penehyclidine impurity 12 (CAS 151673-91-5)
- Piperacillin Sodium EP Impurity G (CAS 63422-71-9)
- 2-(1,2,3,4-tetrahydronaphthalen-1-yl)pyrrolidine (CAS 95092-06-1)
- 1-(3-(1h-Tetrazol-5-yl)phenyl)ethan-1-one (CAS 1105679-23-9)
- Hexanedioic acid, polymer with 1,2-ethanediol and 1,3-isobenzofurandione (CAS 26780-60-9)
- 5-Chloro-4-iodo-1H-pyrazolo[3,4-b]pyridine (CAS 2888535-13-3)
- Tert-butyl 3-(1-(methylamino)propyl)piperidine-1-carboxylate (CAS 1334495-15-6)
- 1,1'-(1,3,4-Oxadiazole-2,5-diyl)diethanone (CAS 215666-58-3)
- Tirzepatide Impurity 23 X TFA Salt (CAS CATO-C4X-324023)
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