Tacrolimus Impurity 31 CAS 123719-19-7
| CAS No. | 123719-19-7 |
| Molecular Formula | C43H69NO11 |
| Molecular Weight | 776.01 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Based on its molecular formula C43H69NO11, Tacrolimus Impurity 31 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 776.01 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
As a process- or degradation-related impurity, Tacrolimus Impurity 31 (CAS 123719-19-7, C43H69NO11) 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 | C43H69NO11 |
| Molecular Weight | 776.01 g/mol |
| Purity | >90% |
| 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) | 10.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1992 |
| Nitrogen Atoms | 1 |
Related Tacrolimus Standards
- Tacrolimus EP Impurity H (CAS 143210-33-7)
- Tacrolimus Impurity 2 (Discontinue) (CAS CATO-C4X-13002)
- Tacrolimus impurity 48 (CAS CATO-C4X-130048)
- Tacrolimus impurity 72 (CAS CATO-C4X-130072)
- Tacrolimus Impurity 52 (CAS CATO-C4X-130052)
- Tacrolimus Impurity 3 (CAS CATO-C4X-13003)
- Tacrolimus EP Impurity I (CAS 104987-16-8)
- Tacrolimus Impurity 54 (CAS CATO-C4X-130054)
Recommended Standards
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