Valsartan Impurity 2393969-04-3
WhatsAPP: +86 17320513646
E-mail: anna@molcoo.com
Valsartan, a non-peptide angiotensin II receptor blocker (ARB), lowers blood pressure by selectively antagonizing AT₁ receptors and is widely used in hypertension and heart failure treatment. In pharmaceutical R&D and quality control, impurity reference standards are critical for ensuring API and formulation safety. This documentation provides high-purity Valsartan impurity reference standards, covering genotoxic impurities (e.g., NDMA, NDEA), degradation products, and process-related impurities (e.g., Impurity A, B, C), suitable for ICH M7 risk assessment, forced degradation studies, and analytical method validation.
Technical Specifications
| Parameter | Details |
|---|
| Purity | ≥99.0% (HPLC area normalization), single impurity ≤0.05% |
| Structural Confirmation | ¹H-NMR, ¹³C-NMR, MS, HPLC, and XRD spectra provided for structural/polymorphic analysis |
| Packaging | 25mg/vial (customizable to 50mg, 100mg; includes SDS) |
| Stability | Inert gas packaging, stored at -20°C (dark), shelf life ≥5 years (accelerated stability data available) |
| Compliance | Aligned with ChP 2025, USP 45, EP 11.0; includes CEP certificate and DMF number |
Applications
Genotoxic Impurity Control: Quantify nitrosamines (e.g., NDMA, NDEA) per ICH M7 guidelines to ensure PDE <1.5 μg/day.
Forced Degradation Studies: Simulate degradation under ICH Q1B (photostability), 60°C/10 days (thermal), and acid/base hydrolysis to establish impurity profiles.
Method Validation: Support UPLC-MS/MS method development for specificity (r²≥0.999), LOQ (≤0.01 ppm), and robustness.
Polymorphism Research: Compare XRD patterns of API and Impurity C to assess bioavailability impacts.
Representative Impurities
| Impurity Code | Chemical Name | CAS No. | Molecular Formula | Molecular Weight | Key Properties |
|---|
| Impurity A | Valsartan Acid (Degradation Product) | 137862-53-4 | C₂₄H₂₉N₅O₃ | 435.52 | Carboxylic acid derivative, pH-dependent degradation |
| Impurity B | Valsartan Isopropyl Ester (Process Impurity) | 137862-51-2 | C₂₇H₃₅N₅O₃ | 477.60 | Prodrug ester, requires residual solvent (isopropanol) control |
| Impurity C | Valsartan D-Enantiomer (Chiral Impurity) | 137862-54-5 | C₂₄H₂₈N₅O₃Cl | 481.97 | Inverted chiral center, 50% reduced efficacy |
| NDMA | N-Nitrosodimethylamine (Genotoxic Impurity) | 62-75-9 | C₂H₆N₂O | 74.08 | IARC Class 2A carcinogen, strict limit (<0.1 ppm) |
Quality Assurance
Full Traceability: Multi-step QC (ID, LC-MS/MS, KF, GC-HS) for each batch.
Spectral Library: Electronic spectra package with retention time, fragmentation patterns, and XRD data.
Custom Synthesis: Isotope-labeled (e.g., ¹⁵N, ¹⁸O) or ultra-low-level genotoxic impurities (<0.01 ppm) available upon request.
WhatsAPP: +86 17320513646
E-mail: anna@molcoo.com
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