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Postion:Product Catalog >Levalbuterol Impurity
Levalbuterol Impurity
  • Levalbuterol Impurity
  • Levalbuterol Impurity
  • Levalbuterol Impurity
  • Levalbuterol Impurity
  • Levalbuterol Impurity

Levalbuterol Impurity NEW

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Package 10mg 50mg 100mg
Min. Order: 10mg
Supply Ability: 1000
Update Time: 2025-07-31

Product Details

Product Name: Levalbuterol Impurity CAS No.: 2919946-71-5
Min. Order: 10mg Purity: 99%+ HPLC
Supply Ability: 1000 Release date: 2025/07/31

Levalbuterol Impurity;2919946-71-5

Article illustration

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:C??H??N?O?

  • 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

Levalbuterol, a selective β?-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.

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 IC?? of 192.5 μM against BEAS-2B cells (Levalbuterol IC??=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! 

Company Profile Introduction

1. Drug standards and drug impurity reference substances: provide more than 20,000 kinds of spot impurity reference substances, with sufficient supply and same-day delivery. We have a professional R&D team and comprehensive quality control testing to ensure product quality and reliability. 2. Customized synthesis of impurities and new molecules: Quickly respond to the customized needs of CDE impurities, stably supply impurities that have established quality standards, and provide customized synthesis services for new compounds in the research and development of innovative drugs. 3. Preparation and separation of unknown impurities: With a professional impurity preparation and separation technical team and SFC preparation and separation instruments, we can solve the problems of impurity preparation in complex projects. 4. Process development of new drug intermediates: provide the supply of new drugs and new molecular impurities, process optimization services, as well as the screening and impurity analysis of commercialization routes. 5. Peptide synthesis: Provide customized peptide synthesis services, and cover all kinds of degradation impurities and process impurities generated in the research and development of peptide drugs. At the same time, it provides comprehensive structural confirmation data and customized testing services.

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