Valsartan Nitroso Impurity C19H20N6O3 

WhatsAPP: +86 17386083646
E-mail: anna@molcoo.com

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• Product Information

• Product Code：V002070

• English Name：Valsartan Nitroso Impurity 70

• English Alias：(S)-2-(((2'-(2H-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl)(nitroso)amino)-3-methylbutanoic acid

• CAS No.：Not provided (to be supplemented)

• Molecular Formula：C??H??N?O?

• Molecular Weight：380.40

• Advantages

• High-Purity Reference Standard：Confirmed by HPLC (≥99.0%), NMR (1H, 13C), HRMS, and elemental analysis, suitable for Valsartan nitroso impurity analysis and quality control.

• Stability Assurance：Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.3% in methanol-water mixture within 6 months.

• Applications

• Quality Control Testing：Used for UPLC-MS/MS detection of Impurity 70 in Valsartan API and formulations, controlling content to meet ICH Q3A standards (single impurity limit ≤0.1%).

• Process Optimization Research：Monitors impurity formation during Valsartan synthesis, reducing generation by >40% by adjusting nitrosation temperature (e.g., 0-5℃) and pH.

• Method Validation：Serves as a standard for developing impurity detection methods, verifying UPLC resolution (≥3.0) and LOD (0.01 ng/mL).

• Background Description

• Valsartan, an angiotensin II receptor antagonist, is used for treating hypertension and heart failure. Impurity 70, a nitroso-related impurity of Valsartan, may originate from side reactions between amino groups and nitrites during synthesis. Its nitroso, tetrazole, and carboxylic acid groups may affect drug stability, receptor binding, and safety. Due to the potential genotoxicity of nitroso compounds, global regulatory agencies have strict control requirements, making research on this impurity crucial for ensuring Valsartan quality.

• Research Status

• Detection Technology：UPLC-MS/MS with C18 column (1.7μm) and 0.1% formic acid-acetonitrile gradient elution achieves separation within 8 minutes, with LOD of 0.005 ng/mL for trace impurity analysis.

• Formation Mechanism：Formed by nitrosation of Valsartan intermediates with nitrites under acidic conditions (e.g., pH < 4); optimizing reaction pH and nitrite dosage inhibits side reactions.

• Safety Evaluation：In vitro cytotoxicity shows IC?? of 186.3 μM against HEK293 cells (Valsartan IC??=9.5 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.

NOTE！

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 17386083646
E-mail: anna@molcoo.com

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