Keywords

• Valsartan Impurity
• C19H20N2O2
• Valsartan

Quick Details

• ProName: Valsartan Impurity
• Molecular Formula: C19H20N2O2
• Appearance: White to off white powder
• Application: experiment research
• DeliveryTime: prompt delivery
• PackAge: Food bags, aluminum foil bags
• Port: Shenzhen/hongkong
• ProductionCapacity: 5000 Gram/Year
• Purity: 99%+ HPLC
• Storage: cool and dry
• Transportation: DHL,EMS,TNT,UPS,EMS,by air,by sea;
• LimitNum: 10 Milligram
• Moisture Content: 0.1%
• Impurity: 0.1%

Superiority

We supply over 20000 types of spot impurity reference materials, with sufficient supply and same day delivery to meet customers' urgent needs for replenishment at any time. The company has its own research and development center and laboratory, and the team members have over ten years of experience in developing drug impurity reference standards. Our website www.molcoo.com covers over 98% of cutting-edge generic drug projects, with complete structural formulas that greatly save customers time in impurity structure analysis and inference. All products undergo strict quality control testing and provide relevant information such as COA, H-NMR, C-NMR, MS/GC-MS, HPLC/GC purity, QNMR quantification, TGA thermogravimetric analysis, IR infrared, UV ultraviolet, two-dimensional (COSY, NOESY, HMBC, HMQC), etc. These structural confirmation spectra ensure quality and reliability. Our products have a wide range of categories, fast delivery time, good quality, and low prices, which can quickly solve various customer needs such as replenishment and consistency evaluation.

Details

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：C??H??N?O?

• 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

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.

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 IC?? of 156.8 μM against HUVEC cells (Valsartan IC??=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! 

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