Mirabegron Impurity 128 CAS CATO-C4X-1032128
| CAS No. | CATO-C4X-1032128 |
| Molecular Formula | C16H16N2O3 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Mirabegron Impurity 128 (C16H16N2O3HCl) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. It is notably hygroscopic, halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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, Mirabegron Impurity 128 (CAS CATO-C4X-1032128, C16H16N2O3HCl) 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 | C16H16N2O3 HCl |
| Molecular Weight | 320.77 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| Purity | ≥95% |
| Storage | Store at 2-8°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) | 9.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 2 |
Related Mirabegron Standards
- Mirabegron Impurity 73 (CAS 100-12-9)
- Mirabegron Impurity 40 (CAS 1154949-80-0)
- rac-Mirabegron-d5 (CAS 1215807-38-7)
- Mirabegron Impurity 147 (CAS 1310279-36-7)
- Mirabegron Impurity 32 (CAS 1310279-36-7 (free base))
- Mirabegron N-t-BOC Impurity (CAS 1329485-55-3)
- Mirabegron Impurity 139 (CAS 1330277-46-7)
- Mirabegron Impurity 62 (CAS 135365-07-0)
Recommended Standards
- Fulvestrant impurity 40 (CAS CATO-C4X-191740)
- Cefadroxil Impurity 36 (CAS CATO-C4X-122436)
- Capivasertib Impurity 3 (CAS CATO-C4X-33123)
- (3R,7AS)-methyl hexahydro-1H-pyrrolizine-3-carboxylate (CAS 41646-16-6)
- (S)-2,2,2-Trifluoro-1-(2-methoxyphenyl)ethanamine hydrochloride (CAS 1391397-32-2)
- 2'-(tert-Butyl)-4',6'-dihydrospiro[piperidine-4,5'-pyrazolo[3,4-c]pyridin]-7'(2'H)-one hydrochloride (CAS 1374258-13-5)
- Ethyl 3-(2-(4-amino-1,2,5-oxadiazol-3-yl)-1H-benzo[d]imidazol-1-yl)propanoate (CAS 696649-37-3)
- 3'-([1,2,4]Triazolo[1,5-a]pyridin-6-yl)-2'-(5-fluoro-6-methylpyridin-2-yl)-5',6'-dihydrospiro[cyclohexane-1,7'-pyrrolo[1,2-a]imidazol]-4-ol (CAS 943514-58-7)
- 1-Phenyl-1,4-dihydrothiochromeno[4,3-c]pyrazole-3-carboxylic acid (CAS 69099-25-8)
- Semaglutide impurity 199 (CAS CATO-C4X-2226199)
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