Mirtazapine
General Information
Mirtazapine Impurities and Mirtazapine
Daicel Pharma offers high-quality Mirtazapine impurities, such as N-Desmethyl Mirtazapine. It is vital for evaluating Mirtazapine quality, stability, and biological safety. In addition, Daicel Pharma specializes in the custom synthesis of Mirtazapine impurities and ensures their worldwide delivery.
Mirtazapine [CAS: 85650-52-8] is a tetracyclic, benzazepine compound that treats major depressive disorders. It is an antagonist of histamine H1 receptors, which gives it sedative properties. In addition, it is an anxiolytic drug for treating anxiety disorders.
Mirtazapine: Use and Commercial Availability
As an antidepressant, Mirtazapine treats major depressive disorders. Further, it treats panic disorder, insomnia, social anxiety disorder, fibromyalgia, etc. It has a sedating, calming effect as it is a histamine receptor antagonist. The significant metabolites of Mirtazapine include N-desmethyl and N-oxide metabolite. It is administered orally to patients. Remeron and Remeron soltab are the brand names of Mirtazapine.
Mirtazapine Structure and Mechanism of Action
The chemical name of Mirtazapine is 1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c][2]benzazepine. The chemical formula for Mirtazapine is C17H19N3 and its molecular weight is approximately 265.35 g/mol.
Mirtazapine increases the release of serotonin and norepinephrine by blocking the central alpha-2 adrenergic receptors that are presynaptic.
Mirtazapine Impurities and Synthesis
While synthesizing Mirtazapine 1, impurities may form that affect the safety and efficacy of the drug. During the production and storage of Mirtazapine, impurities form. Thus, the control and monitoring of Mirtazapine impurities is essential in every stage of drug development.
Daicel Pharma offers a comprehensive Certificate of Analysis (CoA) for Mirtazapine impurities, which includes N-Desmethyl Mirtazapine. The issued CoA is from a cGMP-compliant analytical facility. It contains detailed characterization data such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity2. We give additional data like 13C-DEPT and CHN on request. Daicel Pharma can make any unidentified Mirtazapine impurities or degradation products. In addition, Daicel Pharma offers highly purified isotope-labeled standards of Mirtazapine for bioanalytical research and BA/BE studies. Daicel also supplies genotoxic impurity, N-Nitroso Mirtazapine, with a complete characterization report on delivery.
References
FAQ's
References
- Van der Burg, Willem J., Tetracyclic compounds, GB1543171A. March 28, 1979, AKZO N. V., Netherlands
- Maris, F. A.; Dingler, E.; Niehues, S., High-performance liquid chromatographic assay with fluorescence detection for the routine monitoring of the antidepressant mirtazapine and its demethyl metabolite in human plasma, Journal of Chromatography B: Biomedical Sciences and Applications, Volume: 721, Issue: 2, Pages: 309-316, 1999 DOI: (10.1016/s0378-4347(98)00460-5)
Frequently Asked Questions
How do we separate Mirtazapine impurities from the drug product?
High-performance thin layer chromatography (HPTLC) is the analytical method to separate Mirtazapine impurities from the drug product.
What are the reasons for conducting impurity profiling of Mirtazapine impurities?
Regulatory requirements and maintaining drug quality are the reasons for conducting impurity profiling of Mirtazapine impurities.
What are the conditions under which Mirtazapine undergoes degradation?
Mirtazapine degrades under alkaline, acidic, photolytic, and oxidative conditions.
Note: Products protected by valid patents by a manufacturer are not offered for sale in countries having patent protection. The sale of such products constitutes a patent infringement, and its liability is at the buyer's risk.