Pregabalin impurity 01 CAS 466678-45-5
| CAS No. | 466678-45-5 |
| Molecular Formula | C20H35NO11 |
| Molecular Weight | 465.49 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.
Pregabalin impurity 01 (CAS 466678-45-5) is a certified pharmaceutical impurity reference standard with the molecular formula C20H35NO11 and a molecular weight of 465.49 g/mol.
Based on its molecular formula C20H35NO11, Pregabalin impurity 01 contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 465.49 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.
Physical & Chemical Properties
| Molecular Formula | C20H35NO11 |
| Molecular Weight | 465.49 g/mol |
| Appearance | Off-white to pale yellow crystalline powder |
| Purity | 97%+ |
| Storage | Store at room temperature, 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) | 4.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 2025 |
| Nitrogen Atoms | 1 |
Related Pregabalin Standards
- Pregabalin Impurity PD224378 (CAS 501665-88-9)
- Pregabalin Impurity 113 (CAS CATO-C4X-1312113)
- Pregabalin Impurity 152 (CAS CATO-C4X-1312152)
- Pregabalin Lactose Conjugate Impurity (CAS CATO-C4X-131239)
- Pregabalin Impurity PD 0224378 (CAS CATO-C4X-13124)
- Pregabalin Impurity PD3102236 (CAS 466678-46-6)
- Pregabalin impurity 92 (CAS CATO-C4X-131292)
- Pregabalin impurity 109 (CAS CATO-C4X-1312109)
Recommended Standards
- Phenylpropyl 2-acetamido-3-4-6-tri-O-acetyl-2-deoxy-β-D-glucopyranoside (CAS 220341-05-9)
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- 2-(3,4-Dimethylphenyl)-4-((2-hydroxy-3'-(2H-tetrazol-5-yl)-[1,1'-biphenyl]-3-yl)diazenyl)-5-methyl-2,4-dihydro-3H-pyrazol-3-one (CAS 376592-42-6)
- 2-[(3R,4S)-3-(1,3-Benzodioxol-5-Yloxymethyl)-4-(4-Fluorophenyl)Piperidin-1-Yl]-1-(4-Fluorophenyl)Ethanone (CAS 176894-09-0)
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- Orforglipron Impurity 3 (CAS 2212022-55-2)
- N-(4-Chlorophenyl)-N-[4-(4-methylphenyl)-1,3-thiazol-2-yl]urea (CAS 325978-12-9)
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- Daprodustat impurity 3 (CAS CATO-C4X-24073)
- Valosin Peptide (VQY), porcine (CAS 99510-37-9)
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