Trimetazidine EP Impurity H CAS 53531-01-4
| CAS No. | 53531-01-4 |
| Molecular Formula | C17H26N2O5 |
| Molecular Weight | 338.40 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, Trimetazidine EP Impurity H is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 338.40 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.
Trimetazidine EP Impurity H (CAS 53531-01-4) is a certified pharmaceutical impurity reference standard with the molecular formula C17H26N2O5 and a molecular weight of 338.40 g/mol.
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 | C17H26N2O5 |
| Molecular Weight | 338.40 g/mol |
| Appearance | Off-white to pale 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) | 6.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1972 |
| Nitrogen Atoms | 2 |
Related Trimetazidine Standards
- Trimetazidine Impurity 24 (CAS 92432-50-3)
- Trimetazidine Impurity 28 (CAS CATO-C4X-180328)
- Trimetazidine Impurity 29 (CAS CATO-C4X-180329)
- Trimetazidine Impurity 30 (CAS CATO-C4X-180330)
- Trimetazidine Impurity 13 (CAS 92700-82-8)
- Trimetazidine Impurity 18 (CAS CATO-C4X-180318)
- Trimetazidine Impurity 2 (CAS 93152-26-2)
- Trimetazidine-d8 Dihydrochloride (CAS 1219908-67-4)
Recommended Standards
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- Ilaprazole Impurity1 112 (CAS CATO-C4X-1130112)
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- 4-Amino-3-bromo-5-fluorobenzoic acid (CAS 1027512-98-6)
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