Levalbuterol Impurity NEW

Levalbuterol Impurity;2919946-71-5

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

Product Information

• Product Code：L025012

• English Name：Levalbuterol Impurity 12

• English Alias：N-(tert-butyl)-N-(2-hydroxy-2-(4-hydroxy-3-(hydroxymethyl)phenyl)ethyl)nitrous amide

• CAS No.：2919946-71-5

• Molecular Formula：C₁₃H₂₀N₂O₄

• Molecular Weight：268.31

Advantages

• High-Purity Reference Standard：Confirmed by HPLC (≥99.0%), NMR (1H, 13C), HRMS, and elemental analysis, suitable for Levalbuterol 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 12 in Levalbuterol API and formulations, controlling content to meet ICH Q3A standards (single impurity limit ≤0.1%).

• Process Optimization Research：Monitors Impurity 12 formation during Levalbuterol synthesis, reducing generation by >40% by adjusting nitrosation temperature (e.g., 0-5℃) and reaction time.

• Method Validation：Serves as a standard for developing 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 6 minutes, with LOD of 0.005 ng/mL for trace impurity analysis.

• Formation Mechanism：Formed by nitrosation of tert-butylamine-containing intermediates with sodium nitrite under acidic conditions (e.g., hydrochloric acid system); optimizing acid concentration and reaction time inhibits side reactions.

• Safety Evaluation：In vitro cytotoxicity shows IC₅₀ of 192.5 μM against BEAS-2B cells (Levalbuterol IC₅₀=7.8 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

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!