| CAS No. | 875826-86-1 |
| Molecular Formula | C8H18N2O2 |
| Molecular Weight | 174.24 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 Levocarnitine Impurity 44.
As a process- or degradation-related impurity, Levocarnitine Impurity 44 (CAS 875826-86-1, C8H18N2O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Based on its molecular formula C8H18N2O2, Levocarnitine Impurity 44 contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic functional-group stretching vibrations in infrared spectroscopy. The molecular weight of 174.24 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.
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), Levocarnitine Impurity 44 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 | C8H18N2O2 |
| Molecular Weight | 174.24 g/mol |
| Purity | ≥95% |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening |
| Degree of Unsaturation (DBE) | 1.0 |
| CAS Registry Year (est.) | 1987 |
| Nitrogen Atoms | 2 |