N-Nitroso Isoproterenol Impurity 1 NEW

N-Nitroso Isoproterenol Impurity 1

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

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• Product Information

• Product Number: I035008

• English Name: N-Nitroso Isoproterenol Impurity 1

• English Alias: N-(2-(3,4-dihydroxyphenyl)-2-hydroxyethyl)-N-isopropylnitrous amide

• CAS Number: None

• Molecular Formula: C₁₁H₁₆N₂O₄

• Molecular Weight: 240.26

• Advantages

• As a nitroso impurity reference standard for isoproterenol, this compound has the following advantages:
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• With a well-defined structure and good stability, it can be precisely used to analyze the by-product formation mechanism of nitrosation reactions during isoproterenol synthesis or storage, optimizing processes to control the generation of nitroso impurities.

• Containing multiple functional groups such as nitroso, phenolic hydroxyl, and alcoholic hydroxyl groups, it can provide a standard substance for the detection of nitroso impurities in drugs, significantly improving the quantitative accuracy of detection methods such as HPLC and LC-MS.

• It helps to study the impact of nitroso and polyhydroxy structures on drug stability and toxicological properties, providing a scientific basis for impurity control strategies and ensuring drug safety.

• Applications

• Drug Development: During the research and development of isoproterenol and its formulations, it is used as an impurity reference standard to identify and quantitatively analyze N-Nitroso Isoproterenol Impurity 1, accurately evaluating the purity of APIs and formulations.

• Quality Control: As a standard substance, it is used to verify the sensitivity and specificity of detection methods such as HPLC and LC-MS, ensuring that the content of this impurity during production meets pharmacopoeia and relevant regulatory requirements.

• Toxicological Research: Assisting in evaluating the potential genotoxicity of nitroso impurities, providing data support for drug safety evaluation through in vitro cytotoxicity experiments and animal models.

• Background Description

• Isoproterenol is a β-adrenergic receptor agonist commonly used in the treatment of cardiac arrest, bronchial asthma, and other diseases. Due to the potential carcinogenicity and genotoxicity of nitroso compounds, drug regulatory authorities around the world strictly control nitroso impurities in drugs. N-Nitroso Isoproterenol Impurity 1, as a nitroso impurity of isoproterenol, may be generated during synthesis, storage, or metabolism. Therefore, research on it is a crucial part of drug quality control and safety assessment.

• Research Status

• Currently, research on N-Nitroso Isoproterenol Impurity 1 mainly focuses on the following aspects:
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• Detection Method Optimization: Using advanced technologies such as ultra-high-performance liquid chromatography - tandem mass spectrometry (UPLC-MS/MS) and high-resolution mass spectrometry (HRMS) to develop highly sensitive and selective detection methods for trace detection of this impurity.

• Synthesis Process Improvement: Deeply studying the formation pathway of this impurity, and developing synthesis processes that reduce impurity generation by optimizing reaction conditions (such as reaction temperature, time, solvent selection) and raw material ratios.

• Toxicological Evaluation: Evaluating the potential toxicity of this impurity through in vitro cytotoxicity experiments and animal models, providing data support for scientifically formulating reasonable impurity limit standards.

• Stability Studies: Systematically studying the stability of this impurity under the influence of different environmental factors (light, high temperature, high humidity), analyzing its impact on the quality of isoproterenol formulations, and further improving the drug quality control system.

This product is intended for laboratory use only!

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