Tadalafil Impurity 49 CAS 1379883-12-1
| CAS No. | 1379883-12-1 |
| Molecular Formula | C12H14N2O2 |
| Molecular Weight | 218.25 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Structurally, Tadalafil Impurity 49 (C12H14N2O2) contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 7.0, corresponding to approximately 7 ring(s) or double-bond equivalent(s). With a molecular weight of 218.25 g/mol, it falls into the medium-molecular-weight range. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
Tadalafil Impurity 49 (CAS 1379883-12-1) is a certified pharmaceutical impurity reference standard with the molecular formula C12H14N2O2 and a molecular weight of 218.25 g/mol.
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 | C12H14N2O2 |
| Molecular Weight | 218.25 g/mol |
| Appearance | Off-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 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) | 7.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1991 |
| Nitrogen Atoms | 2 |
Related Tadalafil Standards
- Tadalafil Impurity 36 (CAS 4299-70-1)
- Tadalafil Impurity 88 (CAS 22032-65-1)
- Tadalafil Impurity 161 (CAS CATO-C4X-1087161)
- Tadalafil Impurity 117 (CAS CATO-C4X-1087117)
- Tadalafil Impurity 119 (CAS CATO-C4X-1087119)
- Tadalafil Impurity N27 (CAS 21753-16-2)
- Tadalafil Impurity 163 (CAS CATO-C4X-1087163)
- Tadalafil Impurity 164 (CAS 58979-02-5)
Recommended Standards
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- Ticagrelor Impurity 19 (CAS 1345413-20-8(free base))
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- Methyl 1,2-dimethyl-1H-benzo[d]imidazole-6-carboxylate (CAS 1038387-93-7)
- 5,6-Dimethylisoindolin-1-one (CAS 110568-65-5)
- (Pro30,Tyr32,Leu34)-Neuropeptide Y (28-36) (CAS 161650-01-7)
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