Valsartan EP Impurity B CAS 137863-20-8
| CAS No. | 137863-20-8 |
| Molecular Formula | C31H35N5O3 |
| Molecular Weight | 525.64 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 Valsartan EP Impurity B.
CATO supplies Valsartan EP Impurity B (CAS 137863-20-8), a pharmacopoeial impurity reference standard (molecular formula C31H35N5O3, MW 525.64 g/mol) used for the identification and quantification of trace impurities in APIs.
Structurally, Valsartan EP Impurity B (C31H35N5O3) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 17.0, corresponding to approximately 17 ring(s) or double-bond equivalent(s). With a molecular weight of 525.64 g/mol, it falls into the moderately-high-molecular-weight range. 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 | C31H35N5O3 |
| Molecular Weight | 525.64 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| Purity | >95% |
| 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) | 17.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1996 |
| Nitrogen Atoms | 5 |
Related Valsartan Standards
- Valsartan Impurity 150 (CAS CATO-C4X-1057150)
- Valsartan Impurity 64 (CAS 143618-44-4)
- Valsartan Impurity 49 (CAS CATO-C4X-105749)
- Valsartan Impurity 28 (CAS 154709-17-8)
- Valsartan Impurity 57 (CAS 1353844-77-5)
- 4-Oxo Valsartan Benzyl Ester (CAS 188240-32-6)
- Valsartan Impurity 118 (CAS CATO-C4X-1057118)
- Valsartan Impurity 119 (CAS CATO-C4X-1057119)
Recommended Standards
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- Almonertinib (CAS 1899921-05-1)
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- (6-methyl-3-pyridinyl)boronic acid (6-methyl-3-pyridyl)boronic acid (6-methylpyridin-3-yl)boronic acid 6-Methylpyridine-3-boronic acid 659742-21-9 (CAS 659742-21-9)
- 3-Chloro-N-(4-chloro-2-(trifluoromethyl)phenyl)propanamide (CAS 1016674-58-0)
- N-Methoxy-N-methyl-6-quinoxalinecarboxamide (CAS 875558-38-6)
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- Salbutamol Impurity 184 (CAS CATO-C4X-1176184)
- Pancreatic Polypeptide (bovine) (CAS 179986-89-1)
Why CATO?
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