Bilastine Impurity 25 CAS 137076-22-3
| CAS No. | 137076-22-3 |
| Molecular Formula | C11H19NO3 |
| Molecular Weight | 213.27 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a process- or degradation-related impurity, Bilastine Impurity 25 (CAS 137076-22-3, C11H19NO3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Based on its molecular formula C11H19NO3, Bilastine Impurity 25 contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 213.27 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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 | C11H19NO3 |
| Molecular Weight | 213.27 g/mol |
| Appearance | White to pale yellow crystalline powder |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, ethanol, DMSO |
| 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 |
| CAS Registry Year (est.) | 1996 |
| Nitrogen Atoms | 1 |
Related Bilastine Standards
- Bilastine impurity 120 (CAS 2409938-73-2)
- Bilastine Impurity 73 (CAS 874895-87-1)
- Bilastine impurity 117 (CAS 926245-76-3)
- Bilastine Impurity 37 (CAS 552301-45-8)
- Bilastine impurity 80 (CAS 1789305-52-7)
- Bilastine Impurity 5 (CAS 38385-95-4)
- Bilastine Impurity 40 (CAS 2199440-16-7)
- Bilastine impurity 90 (CAS CATO-C4X-225390)
Recommended Standards
- Brivaracetam Impurity 54 (CAS CATO-C4X-200754)
- Daprodustat Impurity 32 (CAS CATO-C4X-240732)
- Brivaracetam Impurity 53 (CAS CATO-C4X-200753)
- 2,4,5-Trimethyl-1-phenyl-1h-pyrrole-3-carbaldehyde (CAS 100710-49-4)
- Terbinafine lmpurity 28 (CAS 852616-90-1)
- Evocalcet impurity 51 (CAS CATO-C4X-248551)
- Hydrochlorothiazide Impurity 12 (CAS 5250-72-6)
- Atorvastatin Impurity 55 (CAS 196085-84-4)
- Ethanolamine Impurity 5 (CAS 1395890-46-6)
- 2-Bromo-N-((tetrahydrofuran-2-yl)methyl)acetamide (CAS 90271-69-5)
- 4-(Azetidin-3-yloxy)-N-methylbutanamide (CAS 1341175-84-5)
- O-Ethyl di(piperazin-1-yl)phosphinothioate (CAS 61644-91-5)
- 3-Isopropylpiperidin-3-ol (CAS 1339027-25-6)
- Insulin Degludec Impurity 6 (CAS CATO-C4X-21576)
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