Alverine Nitroso Impurity NEW

Alverine Nitroso Impurity;13125-63-8

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

Product Information

• Product Code：A076006

• English Name：Alverine Nitroso Impurity 6

• English Alias：N-ethyl-N-(3-phenylpropyl)nitrous amide

• CAS No.：Not provided

• Molecular Formula：C₁₁H₁₆N₂O

• Molecular Weight：192.26

Advantages

• High-Purity Reference Standard：Confirmed by HPLC (≥99.0%), NMR (1H, 13C), HRMS, and elemental analysis, suitable for Alverine 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 N-nitroso Impurity 6 in Alverine API and formulations, controlling content to meet ICH Q3A standards (single impurity limit ≤0.1%).

• Process Optimization Research：Monitors nitroso impurity formation during Alverine synthesis, reducing generation by >40% by adjusting reaction system pH (e.g., neutral to weakly alkaline) and temperature (≤30℃).

• Method Validation：Serves as a standard for developing nitroso impurity detection methods, verifying UPLC resolution (≥3.0) and LOD (0.01 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 7 minutes, with LOD of 0.002 ng/mL for trace analysis of genotoxic impurities.

• Formation Mechanism：Formed by reaction of Alverine's secondary amine group with nitrite under acidic conditions (e.g., pH <4); optimizing nitrosating agent residue control and post-reaction processing inhibits formation.

• Safety Evaluation：In vitro Ames test shows potential mutagenicity, and in vivo rat model tests demonstrate DNA adduct formation in liver tissue at a 5 mg/kg dose. Accelerated stability and forced degradation tests are ongoing to systematically study degradation pathways and mutagenic risks under light, heat, and oxidation 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

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!