Tetracaine Impurity 40 CAS 63069-46-5
| CAS No. | 63069-46-5 |
| Molecular Formula | C16H16N2O3 |
| Molecular Weight | 284.31 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 Tetracaine Impurity 40.
As a process- or degradation-related impurity, Tetracaine Impurity 40 (CAS 63069-46-5, C16H16N2O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Structurally, Tetracaine Impurity 40 (C16H16N2O3) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 10.0, corresponding to approximately 10 ring(s) or double-bond equivalent(s). With a molecular weight of 284.31 g/mol, it falls into the medium-molecular-weight range. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
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 | C16H16N2O3 |
| Molecular Weight | 284.31 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| Purity | ≥95% |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening |
| Degree of Unsaturation (DBE) | 10.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1975 |
| Nitrogen Atoms | 2 |
Related Tetracaine Standards
- Tetracaine Impurity 9 (CAS 55750-02-2)
- Tetracaine Impurity 30 (CAS CATO-C4X-192330)
- Tetracaine Impurity 35 (CAS CATO-C4X-192335)
- Tetracaine Impurity 10 (CAS 65213-46-9)
- Tetracaine-d6 (CAS 756771-02-5)
- Tetracaine Impurity 29 (CAS CATO-C4X-192329)
- Tetracaine (CAS 94-24-6)
- Tetracaine Impurity 18 (CAS 398469-99-3)
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- Tirzepatide Impurity 36 (CAS CATO-C4X-324036)
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