pregabalin Impurity 37 CAS CATO-C4X-131237
| CAS No. | CATO-C4X-131237 |
| Molecular Formula | C10H17NO3 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
pregabalin Impurity 37 (C10H17NO3) contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, 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 high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.
As a process- or degradation-related impurity, pregabalin Impurity 37 (CAS CATO-C4X-131237, C10H17NO3) 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), pregabalin Impurity 37 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 |
| Nitrogen Atoms | 1 |
Related pregabalin Standards
- Pregabalin Impurity 19 (CAS 104700-36-9)
- Pregabalin Impurity 79 (CAS 105-56-6)
- Pregabalin Impurity 15 (CAS 1083246-65-4)
- Pregabalin Amine Amido (CAS 1094517-69-7)
- Pregabalin Impurity 048 D-Tartrate (CAS 1094517-98-2)
- Pregabalin Impurity 46 (CAS 1101167-84-3)
- Pregabalin Impurity 116 (CAS 1101167-84-3（free base）)
- Pregabalin Impurity 29 (CAS 1136478-28-8)
Recommended Standards
- Tofacitinib impurity 195 (CAS CATO-C4X-1079195)
- Hyoscyamine Impurity 12 (CAS CATO-C4X-343712)
- Cefalotin EP Impurity B (CAS 5935-65-9)
- 3-(4-(Benzyloxy)phenyl)-N'-(pyridin-2-ylmethylene)-1H-pyrazole-5-carbohydrazide (CAS 303104-87-2)
- Tofacitinib Impurity 200 (CAS 1206824-85-2)
- Rivaroxaban Impurity 206 (CAS CATO-C4X-1090206)
- 5(6)-TAMRA-X NHS Ester (CAS 527687-02-1)
- 4,6-Diamino-1-(4-methoxyphenyl)-2-oxo-2,3-dihydro-1h-pyrrolo[2,3-b]pyridine-5-carbonitrile (CAS 124476-83-1)
- 2-(2,6-Dimethylphenoxy)ethane-1-sulfonyl chloride (CAS 1018548-31-6)
- Pancreatic Polypeptide (31-36), amide, human (CAS 74012-13-8)
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