Tepotinib Impurity N13 CAS 1946826-82-9
| CAS No. | 1946826-82-9 |
| Molecular Formula | C29H28N6O2 |
| Molecular Weight | N/A |
| 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, Tepotinib Impurity N13 (CAS 1946826-82-9, C29H28N6O2HClH2O) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Based on its molecular formula C29H28N6O2HClH2O, Tepotinib Impurity N13 contains a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 547.06 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
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 | C29H28N6O2 HCl H2O |
| Molecular Weight | 547.06 g/mol |
| Appearance | Pale yellow to 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) | 17.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1996 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 6 |
Related Tepotinib Standards
- Tepotinib (CAS 1100598-32-0)
- Tepotinib Impurity N54 (CAS 1103506-79-1)
- Tepotinib impurity 1 (CAS 1103506-80-4)
- Tepotinib impurity 3 (CAS 1103506-82-6)
- Tepotinib Impurity 36 (CAS 1103507-25-0)
- Tepotinib impurity 7 (CAS 1103507-26-1)
- Tepotinib Impurity 35 (CAS 1103507-32-9)
- Tepotinib impurity 19 (CAS 1103508-21-9)
Recommended Standards
- Verapamil EP Impurity N HCl (CAS 2086274-75-9 (free base))
- Loteprednol Impurity 8 (CAS 129260-79-3)
- Desmopressin Impurity 16 (CAS CATO-C4X-221516)
- 7,7-Azo-3-α,12-α-dihydroxycholanic Acid (CAS 86992-52-1)
- Methyl 3-(1-Imidazolyl)benzoate (CAS 335255-85-1)
- 3-Methyl-[1,2,3]triazolo[1,5-a]pyridin-5-amine (CAS 2879235-02-4)
- Raltegravir EP Impurity A (CAS 518048-03-8)
- 2,3-difluoroquinoxaline (CAS 7066-36-6)
- Tetraphenylphosphonium tetrafluoroborate (CAS 426-79-9)
- Retatrutide (CAS 2381089-83-2)
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