| CAS No. | 140235-34-3 |
| Molecular Formula | C5H8O5 |
| Molecular Weight | 148.11 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Malic Acid Impurity 2 (C5H8O5) contains a carbohydrate-derived structure. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions.
Malic Acid Impurity 2 (CAS 140235-34-3) is a certified pharmaceutical impurity reference standard with the molecular formula C5H8O5 and a molecular weight of 148.11 g/mol.
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 | C5H8O5 |
| Molecular Weight | 148.11 g/mol |
| Purity | >95% |
| Storage | Store at 2-8°C, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, ethanol, DMSO, water |
| Stability | Hygroscopic; reseal immediately after opening |
| Degree of Unsaturation (DBE) | 2.0 |
| CAS Registry Year (est.) | 1997 |