Gabapentin EP Impurity D CAS 1076198-17-8
| CAS No. | 1076198-17-8 |
| Molecular Formula | C18H29NO3 |
| Molecular Weight | 307.43 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.
As a process- or degradation-related impurity, Gabapentin EP Impurity D (CAS 1076198-17-8, C18H29NO3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Gabapentin EP Impurity D (C18H29NO3) contains a steroid core, an amide group, a hydroxyl group, an ether linkage. Its high carbon-to-hydrogen ratio confers good lipid solubility, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).
As a certified reference material (CRM), Gabapentin EP Impurity D 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.
Physical & Chemical Properties
| Molecular Formula | C18H29NO3 |
| Molecular Weight | 307.43 g/mol |
| Appearance | Off-white to pale yellow crystalline powder |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 5.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1988 |
| Nitrogen Atoms | 1 |
Related Gabapentin Standards
- Gabapentin Impurity 22 (CAS CATO-C4X-165422)
- Gabapentin impurity 35 (CAS CATO-C4X-165435)
- Gabapentin Impurity 38 (CAS 3048030-55-0)
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- Gabapentin Impurity 21 (CAS CATO-C4X-165421)
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