| CAS No. | 164262-23-1 |
| Molecular Formula | C12H26N4O3 |
| Molecular Weight | N/A |
| 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 Lysine Impurity 22 Trihydrochloride.
As a process- or degradation-related impurity, Lysine Impurity 22 Trihydrochloride (CAS 164262-23-1, C12H26N4O3HCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Owing to an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution, Lysine Impurity 22 Trihydrochloride is typically white to off-white crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 310.82 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
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), Lysine Impurity 22 Trihydrochloride 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 | C12H26N4O3 3*HCl |
| Molecular Weight | 310.82 g/mol |
| Purity | 97%+ |
| 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; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 1.0 |
| CAS Registry Year (est.) | 2003 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 4 |