Dolutegravir Impurity 13 CAS 1646862-02-3
| CAS No. | 1646862-02-3 |
| Molecular Formula | C14H19NO8 |
| Molecular Weight | 329.30 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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.
As a process- or degradation-related impurity, Dolutegravir Impurity 13 (CAS 1646862-02-3, C14H19NO8) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Based on its molecular formula C14H19NO8, Dolutegravir Impurity 13 contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 329.30 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
As a certified reference material (CRM), Dolutegravir Impurity 13 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.
Physical & Chemical Properties
| Molecular Formula | C14H19NO8 |
| Molecular Weight | 329.30 g/mol |
| Appearance | Off-white to pale yellow crystalline powder |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening |
| Degree of Unsaturation (DBE) | 6.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1993 |
| Nitrogen Atoms | 1 |
Related Dolutegravir Standards
- Dolutegravir Impurity 57 (CAS 2958649-37-9)
- Dolutegravir Impurity 63 (CAS CATO-C4X-162063)
- Dolutegravir Impurity 56 (CAS CATO-C4X-162056)
- Dolutegravir Impurity N1 (CAS 1335210-34-8)
- Dolutegravir Impurity 24 (CAS 2315439-81-5)
- Dolutegravir Impurity 25 (CAS 2730133-58-9)
- Dolutegravir Impurity 3 (CAS CATO-C4X-16203)
- Dolutegravir Impurity 41 (CAS CATO-C4X-162041)
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