| CAS No. | 105986-59-2 |
| Molecular Formula | C12H22O2 |
| Molecular Weight | 198.30 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 Thioctic acid Impurity 79.
CATO supplies Thioctic acid Impurity 79 (CAS 105986-59-2), a pharmacopoeial impurity reference standard (molecular formula C12H22O2, MW 198.30 g/mol) used for the identification and quantification of trace impurities in APIs.
The molecular framework of Thioctic acid Impurity 79 (C12H22O2) is characterized by a carboxylic acid group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.
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), Thioctic acid Impurity 79 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 | C12H22O2 |
| Molecular Weight | 198.30 g/mol |
| Purity | ≥95% |
| Storage | Store at 2-8°C |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate, DMSO |
| Stability | Stable under recommended storage conditions |
| Degree of Unsaturation (DBE) | 2.0 |
| CAS Registry Year (est.) | 1987 |