Pregabalin Impurity 13 CAS 1136478-30-2
| CAS No. | 1136478-30-2 |
| Molecular Formula | C8H15NO2 |
| Molecular Weight | 157.21 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Pregabalin Impurity 13.
As a process- or degradation-related impurity, Pregabalin Impurity 13 (CAS 1136478-30-2, C8H15NO2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Based on its molecular formula C8H15NO2, Pregabalin Impurity 13 contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic functional-group stretching vibrations in infrared spectroscopy. The molecular weight of 157.21 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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.
As a certified reference material (CRM), Pregabalin Impurity 13 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 | C8H15NO2 |
| Molecular Weight | 157.21 g/mol |
| Purity | >80% |
| Storage | Store at 2-8°C, protect from light |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 2.0 |
| CAS Registry Year (est.) | 1989 |
| Nitrogen Atoms | 1 |
Related Pregabalin Standards
- Pregabalin Impurity 12 (CAS 216576-74-8)
- Pregabalin Impurity 127 (CAS 1956426-34-8)
- Pregabalin Impurity 130 (CAS CATO-C4X-1312130)
- Pregabalin Impurity 20 (CAS CATO-C4X-131220)
- Pregabalin Impurity 45 (CAS 1141362-94-8)
- Pregabalin Impurity 46 (CAS 1101167-84-3)
- Pregabalin Impurity 109 (CAS CATO-C4X-1312110)
- Pregabalin Impurity 89 (CAS CATO-C4X-131289)
Recommended Standards
- Ambroxol Impurity 36 (CAS CATO-C4X-108536)
- Ambroxol Impurity 35 (CAS CATO-C4X-108535)
- Ambroxol Impurity 13 (CAS 27489-60-7)
- (S)-4,5-Dehydro Pregabalin (CAS 1141362-54-0)
- Tenofovir disoproxil Impurity 109 (CAS CATO-C4X-1076109)
- Erlotinib Impurity 56 (CAS CATO-C4X-106956)
- Ozagrel Impurity 40 (CAS 883903-91-1)
- Peptide Impurity 04 (CAS 2913424-91-4)
- 4-Methylpyridine-2-thiol (CAS 18368-65-5)
- Ambroxol EP Impurity D (CAS 107814-37-9)
- N-(3-aminopropyl)-2-(p-tolyl)acetamide hydrochloride (CAS 1568485-13-1)
- 2-(((2,6-Difluorobenzyl)amino)methyl)tetrahydrothiophene 1,1-dioxide (CAS 1428011-15-7)
- 2-(Isochroman-5-yl)-4,4,5,5-tetramethyl-1,3,2-dioxaborolane (CAS 2788905-81-5)
- Tau Peptide (307-321) trifluoroacetate salt (CAS 330456-50-3)
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