Bilastine Impurity 102 CAS 2199440-17-8
| CAS No. | 2199440-17-8 |
| Molecular Formula | C19H27N3O3 |
| Molecular Weight | 345.44 g/mol |
| 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, Bilastine Impurity 102 (CAS 2199440-17-8, C19H27N3O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Structurally, Bilastine Impurity 102 (C19H27N3O3) contains a steroid core, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 8.0, corresponding to approximately 8 ring(s) or double-bond equivalent(s). With a molecular weight of 345.44 g/mol, it falls into the moderately-high-molecular-weight range. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
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 | C19H27N3O3 |
| Molecular Weight | 345.44 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| 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 |
| Degree of Unsaturation (DBE) | 8.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1998 |
| Nitrogen Atoms | 3 |
Related Bilastine Standards
- Bilastine impurity 81 (CAS CATO-C4X-225381)
- Bilastine Impurity 31 (CAS 2818982-86-2)
- Bilastine Impurity 71 (CAS CATO-C4X-225371)
- Bilastine Impurity 72 (CAS CATO-C4X-225372)
- Bilastine Impurity 61 (CAS 2890196-78-6)
- Bilastine impurity 105 (CAS 2052955-68-5)
- Bilastine Impurity 38 (CAS 883106-63-6)
- Bilastine Boc Impurity 32 (CAS 1181267-36-6)
Recommended Standards
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