Levalbuterol Impurity;2919946-71-5
WhatsAPP: +86 17386083646
E-mail: anna@molcoo.com
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
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.
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).
Levalbuterol, a selective β₂-adrenergic receptor agonist, is used for treating asthma and chronic obstructive pulmonary disease (COPD). Impurity 12, as a nitroso-related impurity of Levalbuterol, may originate from nitrosation side reactions of amino groups during synthesis or oxidation during storage. Its nitroso, hydroxyl, and hydroxymethyl groups may affect drug stability and receptor binding. With stricter requirements for respiratory drug impurities, studying this impurity is crucial for ensuring drug quality.
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!
China
