| CAS No. | CATO-C4X-131628 |
| Molecular Formula | C16H30NaO14P |
| Molecular Weight | 500.36 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
The occurrence of Fosfomycin Impurity 28 is closely related to a phosphate ester group, 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 Fosfomycin Impurity 28 (CAS CATO-C4X-131628), a pharmacopoeial impurity reference standard (molecular formula C16H30NaO14P, MW 500.36 g/mol) used for the identification and quantification of trace impurities in APIs.
Structurally, Fosfomycin Impurity 28 (C16H30NaO14P) contains a phosphate ester group, 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 500.36 g/mol, it falls into the moderately-high-molecular-weight range.
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 | C16H30NaO14P |
| Molecular Weight | 500.36 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) | 2.0 |