| CAS No. | 1643116-24-8 |
| Molecular Formula | C9H14N5O4P |
| Molecular Weight | 287.21 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Compared with other compounds in its class, the molecular weight of 287.21 g/mol gives Tenofovir Impurity 68 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.
Tenofovir Impurity 68 (CAS 1643116-24-8) is a certified pharmaceutical impurity reference standard with the molecular formula C9H14N5O4P and a molecular weight of 287.21 g/mol.
Structurally, Tenofovir Impurity 68 (C9H14N5O4P) contains a nitrogen-containing heterocyclic scaffold, an amide group, a phosphate ester group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 5.5, corresponding to approximately 5 ring(s) or double-bond equivalent(s). With a molecular weight of 287.21 g/mol, it falls into the medium-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.
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.
| Molecular Formula | C9H14N5O4P |
| Molecular Weight | 287.21 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (faint amine-like odor) |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, ethanol, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening |
| Degree of Unsaturation (DBE) | 5.5 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1993 |
| Nitrogen Atoms | 5 |