| CAS No. | 4469-34-5 |
| Molecular Formula | C8H14O2 |
| Molecular Weight | 142.20 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Structurally, Pyridoxine Impurity 5 (C8H14O2) contains a carboxylic acid group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 2.0, corresponding to approximately 2 ring(s) or double-bond equivalent(s). With a molecular weight of 142.20 g/mol, it falls into the low-molecular-weight range.
As a process- or degradation-related impurity, Pyridoxine Impurity 5 (CAS 4469-34-5, C8H14O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
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 | C8H14O2 |
| Molecular Weight | 142.20 g/mol |
| Purity | >95% |
| Storage | Store at 2-8°C |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | Stable under recommended storage conditions |
| Degree of Unsaturation (DBE) | 2.0 |
| CAS Registry Year (est.) | 1958 |