| CAS No. | 10367-96-1 |
| Molecular Formula | C13H17ClN2O4 |
| Molecular Weight | 300.74 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
CATO manufactures Procaine Impurity N2 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.
CATO supplies Procaine Impurity N2 (CAS 10367-96-1), a pharmacopoeial impurity reference standard (molecular formula C13H17ClN2O4, MW 300.74 g/mol) used for the identification and quantification of trace impurities in APIs.
Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution, Procaine Impurity N2 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 300.74 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.
| Molecular Formula | C13H17ClN2O4 |
| Molecular Weight | 300.74 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor) |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 6.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1959 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 2 |