| CAS No. | 1083246-63-2 |
| Molecular Formula | C18H32N2O3 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
CATO manufactures Gabapentin Impurity 8 HCl 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 Gabapentin Impurity 8 HCl (CAS 1083246-63-2), a pharmacopoeial impurity reference standard (molecular formula C18H32N2O3HCl, MW 360.92 g/mol) used for the identification and quantification of trace impurities in APIs.
Owing to an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution, Gabapentin Impurity 8 HCl is typically white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 360.92 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.
| Molecular Formula | C18H32N2O3 HCl |
| Molecular Weight | 360.92 g/mol |
| Appearance | 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) | 3.0 |
| UV Absorption | UV-absorbing |
| CAS Registry Year (est.) | 1989 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 2 |