Mianserin Impurity 44 NEW

Mianserin Impurity 44；68998-54-9

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

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• Product Information

• Product Number: M048044

• English Name: Mianserin Impurity 44

• English Alias: 2,2'-((1-hydroxypropan-2-yl)azanediyl)diethanol

• CAS Number: 68998-54-9

• Molecular Formula: C₇H₁₇NO₃

• Molecular Weight: 163.21

• Advantages

• As an impurity reference standard for mianserin, this compound has the following advantages:
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• Well-defined and highly stable structure: A clear amino diol structure containing hydroxyl and secondary amino groups, which can be used to analyze the by-product formation mechanism of amination and hydroxylation reactions in mianserin synthesis, optimizing processes to reduce impurity generation;

• Polyhydroxy standard substance: Characteristic structure with three hydroxyl groups and one amino group, providing an accurate standard for detection methods such as HPLC and LC-MS, improving the separation and quantification accuracy of polar impurities (the polyhydroxy structure enhances water solubility, facilitating adjustment of retention behavior in reversed-phase chromatography);

• Synthetic traceability value: As a potential intermediate impurity in mianserin synthesis, it can trace the purity of raw material amines and the rationality of reaction conditions (e.g., hydrogenation temperature) through changes in its content, providing data support for process optimization.

• Applications

• Drug Development: Used as an impurity reference standard to identify and quantify Impurity 44 in mianserin and its formulations, evaluating the purity of APIs and formulations;

• Quality Control: Acting as a standard substance to validate the sensitivity and specificity of HPLC (equipped with evaporative light scattering detector or mass spectrometer), ensuring the impurity content meets pharmacopoeia and regulatory requirements during production;

• Stability Studies: Investigating the degradation behavior of this impurity under high temperature and humidity (e.g., dehydration reaction), evaluating its impact on the stability of mianserin formulations and assisting in determining storage conditions.

• Background Description

• Mianserin is a tetracyclic antidepressant that acts by regulating serotonin and norepinephrine receptors in the central nervous system. During its synthesis, incomplete ring-opening reaction of amino groups with ethylene oxide or excessive hydroxylation reactions easily generate polyhydroxyamine impurities such as 2,2'-((1-hydroxypropan-2-yl)azanediyl)diethanol. Such impurities may affect drug lipophilicity and bioavailability, making research on mianserin impurities a key part of drug quality control.

• Research Status

• Current research focuses on:
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• Detection method optimization: Using UPLC-MS/MS technology, selecting hydrophilic interaction chromatography (HILIC) columns based on the polar characteristics of polyhydroxy structures to achieve trace detection (detection limits reach ppb level);

• Synthesis process improvement: Reducing the generation of amino over-hydroxyethylation by-products by controlling the dosage of ethylene oxide and reaction pressure;

• Toxicological evaluation: Evaluating the potential impact of this impurity on nerve cells through in vitro cytotoxicity experiments to provide data for formulating reasonable impurity limit standards;

• Structure-property correlation: Studying the influence of polyhydroxy structures on impurity water solubility and permeability, analyzing their potential interference with mianserin formulation dissolution.

This product is intended for laboratory use only!

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