Vinorelbine EP Impurity J Disulfate Salt CAS CATO-C4X-264212
| CAS No. | CATO-C4X-264212 |
| Molecular Formula | C46H56N4O8 |
| Molecular Weight | N/A |
| 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 Vinorelbine EP Impurity J Disulfate Salt.
Vinorelbine EP Impurity J Disulfate Salt (CAS CATO-C4X-264212) is a certified pharmaceutical impurity reference standard with the molecular formula C46H56N4O8H2O4S and a molecular weight of 891.05 g/mol.
Structurally, Vinorelbine EP Impurity J Disulfate Salt (C46H56N4O8H2O4S) contains a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 20.0, corresponding to approximately 20 ring(s) or double-bond equivalent(s). With a molecular weight of 891.05 g/mol, it falls into the high-molecular-weight range. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).
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 | C46H56N4O8 2*H2O4S |
| Molecular Weight | 891.05 g/mol |
| Purity | 97%+ |
| Storage | Store in a cool place (≤25°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) | 20.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Nitrogen Atoms | 4 |
| Sulfur Atoms | 1 |
Related Vinorelbine Standards
- Vinorelbine Bitartrate (CAS 125317-39-7)
- Vinorelbine EP Impurity B (CAS 126347-74-8)
- Vinorelbine EP Impurity H (CAS 220137-33-7)
- Vinorelbine EP Impurity J (CAS 38390-45-3)
- Vinorelbine Impurity E (EP) (CAS 54081-68-4)
- Vinorelbine (CAS 71486-22-1)
- Vinorelbine EP Impurity G (CAS 72311-64-9)
- Vinorelbine Impurity J (EP) Disulfate (CAS 81165-17-5)
Recommended Standards
- Empagliflozin impurity 265 (CAS CATO-C4X-1065265)
- Valdecoxib Impurity 1 (CAS CATO-C4X-14511)
- Valproate Impurity 86 (CAS CATO-C4X-116686)
- 2-(4-(4-Fluorophenyl)piperazin-1-yl)-N-(4-methoxyphenyl)acetamide (CAS 303091-64-7)
- 1-Methyl-N-(2-(methylthio)benzo[d]thiazol-6-yl)-1H-pyrazole-3-carboxamide (CAS 1020489-09-1)
- benzyl N-[2-(4,4-dimethyl-5-oxo-4,5-dihydro-1,3-oxazol-2-yl)propan-2-yl]carbamate (CAS 4576-16-3)
- (1R,5S,8s)-8-((tert-Butyldiphenylsilyl)oxy)-3-azabicyclo[3.2.1]octane (CAS 2763160-39-8)
- 1-(5-Fluoro-3,3-dimethylindolin-1-yl)propan-2-one (CAS 1956376-90-1)
- Cyanine 5-monofunctionalhexanoic acid dye, potassium Salt (CAS 449175-58-0)
- Semaglutide impurity 99 (CAS CATO-C4X-222699)
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