| CAS No. | 54350-53-7 |
| Molecular Formula | C40H82O15 |
| Molecular Weight | 803.07 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
The occurrence of Polidocanol Impurity 4 (Polidocanol E14) is closely related to a carboxylic acid group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
CATO supplies Polidocanol Impurity 4 (Polidocanol E14) (CAS 54350-53-7), a pharmacopoeial impurity reference standard (molecular formula C40H82O15, MW 803.07 g/mol) used for the identification and quantification of trace impurities in APIs.
Based on its molecular formula C40H82O15, Polidocanol Impurity 4 (Polidocanol E14) contains a carboxylic acid group, a hydroxyl group, an ether linkage; these features give the compound characteristic functional-group stretching vibrations in infrared spectroscopy. The molecular weight of 803.07 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry.
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 | C40H82O15 |
| Molecular Weight | 803.07 g/mol |
| Purity | >95% |
| Storage | Store at room temperature, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | Stable under recommended storage conditions |
| Degree of Unsaturation (DBE) | 0.0 |
| CAS Registry Year (est.) | 1972 |