| CAS No. | 3612-80-4 |
| Molecular Formula | C8H9NO3 |
| Molecular Weight | 167.16 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
The occurrence of Nicotine Impurity 15 is closely related to an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
Nicotine Impurity 15 (CAS 3612-80-4) is a certified pharmaceutical impurity reference standard with the molecular formula C8H9NO3 and a molecular weight of 167.16 g/mol.
Owing to an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage, Nicotine Impurity 15 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 167.16 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.
| Molecular Formula | C8H9NO3 |
| Molecular Weight | 167.16 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (faint amine-like odor) |
| Purity | >90% |
| 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) | 5.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1958 |
| Nitrogen Atoms | 1 |