Valsartan Impurity NEW

Valsartan Impurity

Product Information

• 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

Advantages

• 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.

Applications

• 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).

Background Description

Research Status

• 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.

We can also customize related analogues and modified peptides including HPLC, MS, 1H-NMR, MS, HPLC, IR, UV, COA, MSDS.

This product is intended for laboratory use only!

WhatsAPP: +86 17320513646
E-mail: anna@molcoo.com

NEW IN STOCK!

The Molcoo Laboratory added drug impurity reference standards, including Baricitinib, Piperazine, Benzylpenicillin, Tranilast and multiple N-Nitroso drug impurities! Now available for immediate delivery!