| Customization: | Available |
|---|---|
| CAS No.: | 85650-52-8 |
| Formula: | C17h19n3 |
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Product Name: Mirtazapine
CAS NO.: 85650-52-8
Molecular Formula: C17H19N3
Molecular Weight: 265.35
Purity: 99%
Appearance: White Powder
Grade: Pharmaceutical Grade
Introduction:
Mirtazapine (brand names: Avanza, Axit, Calixta, Mirtaz, Mirtazon, Remeron, Zispin) is an atypical antidepressant with noradrenergic and specific serotonergic activity. It blocks the α2 adrenergic auto- and heteroreceptors (enhancing serotonin release), and selectively antagonizes the 5-HT2 serotonin receptors in the central and peripheral nervous system. It also enhances serotonin neurotransmission at the 5-HT1 receptor and blocks the histaminergic (H1) and muscarinic receptors. Mirtazapine is not a serotonin or norepinephrine reuptake inhibitor but may increase serotonin and norepinephrine by other mechanisms of action.
Mirtazapine is a noradrenergic and specific serotonergic antidepressant (NaSSA) introduced by Organon International in the United States in 1996, and is used primarily in the treatment of depression. It is also commonly used as an anxiolytic, hypnotic, antiemetic and appetite stimulant. In structure, mirtazapine can also be classified as a tetracyclic antidepressant (TeCA) and is the 6-aza analogue of mianserin. It is also racemic-occurs as a combination of both (R)-(−)- and (S)-(+)-stereoisomers, both of which are active.
Application:| Items | Standard | Result |
| Appearance | White or off-white powder | Complies |
Identification |
The IR absorption spectrum is accordant with the spectrum obtained with CRS |
Complies |
| Solubility | , Practically insoluble in water,freely soluble in anhydrous ethanol |
Complies |
specific rotation |
-0.10°~+0.10° (anhydrous substance) |
+0.001° |
| Water | ≤3.5% | 2.8% |
| Sulfated ash | ≤0.10% | 0.04% |
| granularity | 80%<75 m | 39.28 m |
| Residual solvents | Ethanol ≤5000ppm | 130ppm |
Impurity |
Impurity A A≤0.10% | ND |
| Impurity B B≤0.10% | ND | |
| Impurity C C≤0.10% | ND | |
| Impurity D D≤0.10% | ND | |
| Impurity E E≤0.10% | ND | |
| Impurity F F≤0.10% | ND | |
| Individual impurity ≤0.10% | ND | |
| Total impurities ≤0.20% | ND | |
Microbial limit test |
aerobic bacteria≤1000CFU/g | <10CFU/g |
| fungus≤1000CFU/g | <10CFU/g | |
| Absence of escherichia coli | ND | |
| Assay | 99.0~101.0%(anhydrous substance) | 100.0% |
| Conclusion | Complies to EP7.0 | |
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