Lansoprazole Impurity 16 CAS CATO-C4X-111316
| CAS No. | CATO-C4X-111316 |
| Molecular Formula | C10H12F3NO2 |
| Molecular Weight | 235.20 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Lansoprazole Impurity 16 (C10H12F3NO2) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. Halogen substitution raises its density and boiling point, 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, Lansoprazole Impurity 16 (CAS CATO-C4X-111316, C10H12F3NO2) 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.
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 | C10H12F3NO2 |
| Molecular Weight | 235.20 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor, faint amine-like odor, low volatility) |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 4.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | F-containing |
| Nitrogen Atoms | 1 |
Related Lansoprazole Standards
- Lansoprazole Impurity 38 (CAS CATO-C4X-111338)
- Lansoprazole Impurity 30 (CAS CATO-C4X-111330)
- Lansoprazole Impurity 48 (CAS CATO-C4X-161248)
- Lansoprazole Impurity 45 (CAS 103577-61-3)
- Lansoprazole Impurity 51 (CAS 103577-66-8)
- Lansoprazole Impurity 48 (CAS 117977-19-2)
- Lansoprazole Impurity 43 (CAS CATO-C4X-111343)
- Lansoprazole Impurity 29 (CAS 163119-28-6)
Recommended Standards
- Aciclovir EP Impurity L (CAS 3056-33-5)
- 1-Bromoundecane 693-67-4 AS03475 HENDECYL BROMIDE LABOTEST-BB LTBB001165 N-UNDECYL BROMIDE UNDECYL BROMIDE (CAS 693-67-4)
- Baloxavir Impurity 119 (CAS CATO-C4X-2108119)
- N,N-Dimethyl-6-nitro-1,2-benzoxazole-3-carboxamide (CAS 400079-09-6)
- Indapamide Impurity 26 (CAS CATO-C4X-140026)
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- Clarithromycin EP Impurity J(Roxithromycin EP Impurity C) HCl (CAS 145645-54-1)
- 3,4-Dichloro-N-(3,4-dimethoxyphenethyl)benzamide (CAS 67616-17-5)
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- 4,6-Dimethyl-2-{4-[(4-methylphenyl)sulfonyl]-1,4-diazepan-1-yl}nicotinonitrile (CAS 478256-89-2)
- γ-Methyl-γ-decanolactone (CAS 7011-83-8)
- Vildagliptin Impurity 101 (CAS 23500-11-0)
- Risperidone RC 2 (CAS 25519-77-1)
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