Valsartan Impurity
Product Code：V001046
English Name：Valsartan Impurity 46
English Alias：(S)-2-(((2'-cyano-[1,1'-biphenyl]-4-yl)methyl)amino)-3-methylbutanoic acid
CAS No.：[Not Available]
Molecular Formula：C₁₉H₂₀N₂O₂
Molecular Weight：308.37
High-Purity Reference Standard：Confirmed by HPLC (≥99.0%), NMR (1H, 13C), HRMS, and elemental analysis, suitable for Valsartan impurity analysis and quality control.
Stability Assurance：Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.2% in acetonitrile-water solution within 6 months.
Quality Control Testing：Used for UPLC-MS/MS detection of Impurity 46 in Valsartan API and formulations, controlling content to meet ICH Q3A standards (single impurity limit ≤0.1%).
Process Optimization Research：Monitors Impurity 46 formation during Valsartan synthesis, reducing generation by >50% by adjusting condensation temperature (e.g., 50-60℃), reaction time, and catalyst dosage.
Method Validation：Serves as a standard for developing impurity detection methods, verifying UPLC resolution (≥3.0) and LOD (0.005 ng/mL).
Valsartan, an angiotensin II receptor antagonist, is widely used for treating hypertension and heart failure. Impurity 46, as a process-related impurity of Valsartan, may originate from incomplete intermediate reactions, side reactions, or raw material residues during multi-step synthesis. Its cyano-biphenyl and aminobutanoic acid groups may affect the drug's stability, safety, and efficacy. Since the 2018 global Valsartan recall due to impurities, regulatory agencies like FDA and EMA have imposed stricter control requirements, making the study of Impurity 46 crucial for ensuring drug quality and patient safety.
Detection Technology：UPLC-MS/MS with C18 column (1.7μm) and 0.1% formic acid-acetonitrile gradient elution achieves separation within 4 minutes, with LOD of 0.002 ng/mL for trace impurity analysis.
Formation Mechanism：Mainly formed during the condensation of cyano-biphenyl intermediates with aminobutanoic acid derivatives. Optimizing the reaction solvent system (e.g., using DMF instead of methanol) and controlling reaction pH (e.g., weakly alkaline) inhibits its formation.
Safety Evaluation：In vitro cytotoxicity shows IC₅₀ of 156.8 μM against HUVEC cells (Valsartan IC₅₀=7.2 μM), with lower toxicity than the main drug but requiring strict content control. Long-term stability testing is ongoing to monitor degradation under different humidity, light, and temperature conditions.
This product is intended for laboratory use only!
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