Pregabalin Impurity 82 CAS CATO-C4X-131282
| CAS No. | CATO-C4X-131282 |
| Molecular Formula | C11H20O4 |
| Molecular Weight | N/A |
| 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 82.
As a process- or degradation-related impurity, Pregabalin Impurity 82 (CAS CATO-C4X-131282, C11H20O4HCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Based on its molecular formula C11H20O4HCl, Pregabalin Impurity 82 contains a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution; these features give the compound characteristic functional-group stretching vibrations in infrared spectroscopy. The molecular weight of 252.73 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
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.
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.
Physical & Chemical Properties
| Molecular Formula | C11H20O4 HCl |
| Molecular Weight | 252.73 g/mol |
| Purity | >95% |
| Storage | Store in a cool place (≤25°C), keep sealed and dry, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in methanol, ethanol, DMSO |
| Stability | Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 1.0 |
| Halogen Content | Cl-containing |
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
- Atorvastatin Impurity 67 (CAS 693793-87-2)
- Sulbactam EP Impurity G (CAS CATO-C4X-17567)
- Revefenacin impurity 32 (CAS CATO-C4X-203132)
- 2-Formyl-4-iodobenzoic acid (CAS 1269493-68-6)
- Methyl 6-amino-4-(2-chlorophenyl)-5-cyano-2-(2-methoxy-2-oxoethyl)-4H-pyran-3-carboxylate (CAS 878656-46-3)
- N-((1-((S)-2-Amino-3-methylbutanoyl)pyrrolidin-3-yl)methyl)acetamide (CAS 1354027-25-0)
- Methyl 3-(4-bromophenyl)-3-(4-methoxybenzenesulfonamido)propanoate (CAS 383148-23-0)
- 16:0 Cyanur PE (CAS 1246304-37-9)
- 1-(3-Methoxybenzyl)-1H-pyrrole-2-carboxylic acid (CAS 1178697-44-3)
- Endo-Pro36-Tirzepatide (CAS CATO-CPTD788688)
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