| CAS No. | 282727-77-9(Free Acid) |
| Molecular Formula | C5H7NO5S |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
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.
CATO supplies Acetylcysteine Impurity 46 Disodium Salt (CAS 282727-77-9(Free Acid)), a pharmacopoeial impurity reference standard (molecular formula C5H7NO5SNa, MW 216.16 g/mol) used for the identification and quantification of trace impurities in APIs.
Acetylcysteine Impurity 46 Disodium Salt (C5H7NO5SNa) contains a carbohydrate-derived structure, an amide group, a sulfone group. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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.
| Molecular Formula | C5H7NO5S 2*Na |
| Molecular Weight | 216.16 g/mol |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, ethanol, DMSO, water |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening |
| Degree of Unsaturation (DBE) | 3.0 |
| UV Absorption | UV-absorbing |
| Nitrogen Atoms | 1 |
| Sulfur Atoms | 1 |