Gadobutrol Impurity 2 CAS CATO-C4X-21202
| CAS No. | CATO-C4X-21202 |
| Molecular Formula | C16H36N4O6 |
| Molecular Weight | 380.48 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Gadobutrol Impurity 2 is closely related to an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
As a process- or degradation-related impurity, Gadobutrol Impurity 2 (CAS CATO-C4X-21202, C16H36N4O6) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Gadobutrol Impurity 2 (C16H36N4O6) contains an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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 | C16H36N4O6 |
| Molecular Weight | 380.48 g/mol |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening |
| Degree of Unsaturation (DBE) | 1.0 |
| Nitrogen Atoms | 4 |
Related Gadobutrol Standards
- Gadobutrol Impurity 145 (CAS CATO-C4X-2120145)
- Gadobutrol impurity 159 (CAS 2892260-33-0)
- Gadobutrol Impurity 133 (CAS 217975-51-4)
- Gadobutrol impurity 32 (CAS 507475-91-4)
- Gadobutrol Impurity 181 (CAS CATO-C4X-2120181)
- Gadobutrol Impurity 107 (CAS 120041-08-9)
- Gadobutrol Impurity 190 (CAS 138884-14-7)
- Gadobutrol Impurity 127 (CAS 216101-03-0)
Recommended Standards
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