| CAS No. | CATO-C4X-250912 |
| Molecular Formula | C6H8O6 |
| Molecular Weight | 176.12 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Malic Acid Impurity 12.
Malic Acid Impurity 12 (CAS CATO-C4X-250912) is a certified pharmaceutical impurity reference standard with the molecular formula C6H8O6 and a molecular weight of 176.12 g/mol.
Malic Acid Impurity 12 (C6H8O6) 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. 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.
As a certified reference material (CRM), Malic Acid Impurity 12 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.
| Molecular Formula | C6H8O6 |
| Molecular Weight | 176.12 g/mol |
| Purity | >95% |
| Storage | Store at 2-8°C, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, ethanol, DMSO, water |
| Stability | May oxidize slowly on prolonged air exposure; Hygroscopic; reseal immediately after opening |
| Degree of Unsaturation (DBE) | 3.0 |
| UV Absorption | UV-absorbing |