Gabapentin Impurity 38 CAS 3048030-55-0
| CAS No. | 3048030-55-0 |
| Molecular Formula | C16H25NO5 |
| Molecular Weight | 311.37 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Structurally, Gabapentin Impurity 38 (C16H25NO5) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 5.0, corresponding to approximately 5 ring(s) or double-bond equivalent(s). With a molecular weight of 311.37 g/mol, it falls into the moderately-high-molecular-weight range. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
As a process- or degradation-related impurity, Gabapentin Impurity 38 (CAS 3048030-55-0, C16H25NO5) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
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 38 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 | C16H25NO5 |
| Molecular Weight | 311.37 g/mol |
| Appearance | Off-white to pale yellow crystalline powder |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| 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.) | 2005 |
| Nitrogen Atoms | 1 |
Related Gabapentin Standards
- Gabapentin EP Impurity D (CAS 1076198-17-8)
- Gabapentin Impurity 22 (CAS CATO-C4X-165422)
- Gabapentin impurity 35 (CAS CATO-C4X-165435)
- Gabapentin impurity 34 (CAS CATO-C4X-165434)
- Gabapentin Impurity 20 (CAS CATO-C4X-165420)
- Gabapentin Impurity 26 (CAS CATO-C4X-165426)
- Gabapentin Impurity 18 (CAS CATO-C4X-165418)
- Gabapentin Impurity 21 (CAS CATO-C4X-165421)
Recommended Standards
- Mianserin impurity 37 (CAS CATO-C4X-136937)
- Dopamine Impurity 101 (CAS CATO-C4X-1908101)
- Bisoprolol Impurity 35 (CAS 1346602-59-2)
- N-4-Benzyloxyphenyl Isobutyrylacetamide (CAS 265989-30-8)
- Ibuprofen EP Impurity E (CAS 38861-78-8)
- Edoxaban Impurity 53 (CAS 1255529-28-2)
- Rosuvastatin Impurity 79 (CAS 488798-36-3)
- 39181-45-8 5-[(4-methylphenyl)methyl]-1,3,4-thiadiazol-2-amine Z1258519601 (CAS 39181-45-8)
- 1-(2-Bromo-5-chlorophenyl)ethan-1-amine hydrochloride (CAS 2205383-86-2)
- 2-amino-1,8-naphthyridine-3-carboxylic acid (CAS 46298-84-4)
- 5-(Bromomethyl)-2-chloro-1,3-difluorobenzene (CAS 1400991-56-1)
- N-(2-Amino-4-bromophenyl)-N-cyclohexyl-N-ethylamine (CAS 1019354-37-0)
- Norepinephrine Impurity 109 (CAS 2731964-60-4)
- Biotinyl-Neuropeptide Y (human, rat) trifluoroacetate salt (CAS 213779-13-6)
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