Valsartan Impurity 78 CAS CATO-C4X-105778
| CAS No. | CATO-C4X-105778 |
| Molecular Formula | C25H31N5O3 |
| Molecular Weight | 449.55 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Valsartan Impurity 78 is closely related to a steroid core, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
Valsartan Impurity 78 (CAS CATO-C4X-105778) is a certified pharmaceutical impurity reference standard with the molecular formula C25H31N5O3 and a molecular weight of 449.55 g/mol.
Valsartan Impurity 78 (C25H31N5O3) contains a steroid core, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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 | C25H31N5O3 |
| Molecular Weight | 449.55 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| 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) | 13.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Nitrogen Atoms | 5 |
Related Valsartan Standards
- Valsartan Impurity 106 (CAS CATO-C4X-1057106)
- Valsartan Impurity 112 (CAS CATO-C4X-1057112)
- Valsartan Impurity 120 (CAS 137863-48-0)
- Valsartan Impurity 125 (CAS 1894176-40-9)
- Valsartan USP Related Compound E (CAS 137863-17-3)
- Valsartan Impurity 73 (CAS CATO-C4X-105773)
- Valsartan Impurity 74 (CAS CATO-C4X-105774)
- Valsartan Impurity 75 (CAS CATO-C4X-105775)
Recommended Standards
- Valsartan Impurity 77 (CAS CATO-C4X-105777)
- Valsartan Impurity 8 (CAS 137862-78-3)
- Valsartan Impurity 76 (CAS CATO-C4X-105776)
- Valsartan Impurity 83 (CAS CATO-C4X-105783)
- Fosaprepitant Impurity 51 (CAS CATO-C4X-116851)
- Ropivacaine EP Impurity E(R-Isomer) (CAS 1050482-18-2)
- Carglumic Acid impurity 01 (CAS 5624-26-0)
- 1-(Bromomethyl)-4-chloro-2-methoxybenzene (CAS 76283-12-0)
- Benzyl 2-(4-acetylphenyl)acetate (CAS 1429507-88-9)
- 2-Amino-4-methoxybenzoic acid hydrochloride (CAS 84575-26-8)
- 4-(4-Bromo-3-fluorophenyl)morpholine (CAS 279261-83-5)
- 4-Cyclopropoxy-2-formyl-N-methylnicotinamide (CAS 1243376-91-1)
- 1,3-Bis(chloromethyl)tetramethyldisiloxane (CAS 2362-10-9)
- Neuropeptide S (rat) (CAS 412938-75-1)
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