Gabapentin Impurity 14 CAS 99189-60-3
| CAS No. | 99189-60-3 |
| Molecular Formula | C10H17NO3 |
| Molecular Weight | 199.25 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a process- or degradation-related impurity, Gabapentin Impurity 14 (CAS 99189-60-3, C10H17NO3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Gabapentin Impurity 14 (C10H17NO3) is characterized by an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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).
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), Gabapentin Impurity 14 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 | C10H17NO3 |
| Molecular Weight | 199.25 g/mol |
| Appearance | White to pale yellow crystalline powder. (faint amine-like odor) |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, ethanol, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening |
| Degree of Unsaturation (DBE) | 3.0 |
| UV Absorption | UV-absorbing |
| CAS Registry Year (est.) | 1985 |
| Nitrogen Atoms | 1 |
Related Gabapentin Standards
- Ethyl gabapentin ester, >98% (CAS 138799-97-0)
- Gabapentin Impurity 9 (CAS 4355-11-7)
- Gabapentin Impurity 19 (CAS 277333-40-1)
- Gabapentin Impurity 39 (CAS CATO-C4X-165439)
- Gabapentin EP Impurity E (CAS 67950-95-2)
- Gabapentin Impurity 15 (CAS 138799-98-1)
- Gabapentin EP Impurity G (CAS 1500558-49-5)
- Gabapentin Impurity 8 (CAS 77877-19-1)
Recommended Standards
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- Ivabradine Impurity 17 (CAS 304462-60-0)
- Phentolamine Mesilate Impurity 4 (CAS CATO-C4X-22474)
- 2-((3-Isopropoxyphenyl)amino)-N-(isoquinolin-6-yl)acetamide (CAS 920513-56-0)
- 3-Chloro-1-pyridin-3-ylmethyl-1H-indazole (CAS 1017781-90-6)
- 3-Chlorobenzoyl Cyanide (CAS 26152-02-3)
- N-(2-methylbut-3-yn-2-yl)-4-phenyl-2-(pyridin-3-yl)pyrimidine-5-carboxamide (CAS 400079-55-2)
- 4-(2-hydroxyethoxy)oxane-4-carbonitrile (CAS 1701845-37-5)
- 2-Bromo-1-(4-chlorophenyl)-2-methyl-1-propanone (CAS 33000-64-5)
- Semaglutide impurity 276 (CAS CATO-C4X-2226276)
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