Tacrolimus EP Impurity D CAS 129212-35-7
| CAS No. | 129212-35-7 |
| Molecular Formula | C44H69NO12 |
| Molecular Weight | 804.02 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 Tacrolimus EP Impurity D.
As a process- or degradation-related impurity, Tacrolimus EP Impurity D (CAS 129212-35-7, C44H69NO12) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Based on its molecular formula C44H69NO12, Tacrolimus EP Impurity D 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 804.02 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.
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 | C44H69NO12 |
| Molecular Weight | 804.02 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) | 11.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1993 |
| Nitrogen Atoms | 1 |
Related Tacrolimus Standards
- Tacrolimus (CAS 104987-11-3)
- Tacrolimus Impurity 15 (CAS CATO-C4X-130015)
- Tacrolimus Impurity 17 (CAS CATO-C4X-130017)
- Tacrolimus EP Impurity F (CAS 1393890-33-9)
- Tacrolimus EP Impurity G (CAS 144490-63-1)
- Tacrolimus Impurity 36 (CAS 131944-48-4)
- Tacrolimus Impurity 37 (CAS CATO-C4X-130037)
- Tacrolimus Impurity 38 (CAS CATO-C4X-130038)
Recommended Standards
- Tacrolimus impurity 67 (CAS CATO-C4X-130067)
- Tacrolimus Lactone Isomer (Iso-FK-506) (CAS 134590-88-8)
- Tacrolimus Impurity 57 (CAS CATO-C4X-130057)
- Semaglutide impurity 63 (CAS CATO-C4X-222663)
- Anamorelin Impurity 11 (CAS CATO-C4X-286911)
- Allisartan Isoproxil Impurity 2 (CAS CATO-C4X-32172)
- Enrofloxacin Impurity 12 (CAS 130579-27-0)
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