Entecavir EP Impurity E CAS 2349444-69-3
| CAS No. | 2349444-69-3 |
| Molecular Formula | C13H17N5O4 |
| Molecular Weight | 307.31 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Entecavir EP Impurity E is closely related to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
Entecavir EP Impurity E (CAS 2349444-69-3) is a certified pharmaceutical impurity reference standard with the molecular formula C13H17N5O4 and a molecular weight of 307.31 g/mol.
Structurally, Entecavir EP Impurity E (C13H17N5O4) contains a nitrogen-containing heterocyclic scaffold, 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 307.31 g/mol, it falls into the moderately-high-molecular-weight range. 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 | C13H17N5O4 |
| Molecular Weight | 307.31 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.) | 1999 |
| Nitrogen Atoms | 5 |
Related Entecavir Standards
- Entecavir Impurity 41 (CAS CATO-C4X-107741)
- Entecavir Impurity 81 (CAS CATO-C4X-107781)
- Entecavir Impurity 57 (CAS 84868-56-4)
- Entecavir Impurity 25 (CAS 110567-22-1)
- Entecavir Impurity 80 (CAS CATO-C4X-107780)
- Entecavir Impurity C182 (CAS 1984788-96-6)
- Entecavir Impurity 16 (Mixture of Diastereomers) (CAS CATO-C4X-107716)
- Entecavir EP Impurity C (CAS 2204369-23-1)
Recommended Standards
- Imatinib Impurity 53 (CAS 152460-09-8)
- Imatinib Impurity 49 (CAS CATO-C4X-106849)
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- Sugammadex Impurity 36 (CAS CATO-C4X-190636)
- Indacaterol Impurity 70 (CAS CATO-C4X-150070)
- Valnemulin impurity 7 (CAS 1350636-92-8)
- 4-Bromo-1-isopentyl-1H-pyrazole-3-carbaldehyde (CAS 1708437-32-4)
- Roxatidine Impurity 37 (CAS CATO-C4X-121337)
- 3,5-Dibromo-1-pentyl-1H-1,2,4-triazole (CAS 1240571-46-3)
- N'-[(1E)-[2-(4-Chlorophenoxy)phenyl]methylidene]-3,4,5-trimethoxybenzohydrazide (CAS 477886-80-9)
- N-(2-Methylphenethyl)-4-propoxyaniline (CAS 1040689-20-0)
- 2-Methyl-5,6-dihydro-4H-imidazo[1,5,4-de]quinoxaline (CAS 114163-46-1)
- Insulin Degludec Impurity 28 (CAS CATO-C4X-215728)
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