Mirtazapine
| Produktname | Mirtazapine |
|---|---|
| CAS-Nummer | 61337-67-5 |
| Molekülformel | C17H19N3 |
| Molekulargewicht | 265.35 g/mol |
| Aussehen | Weißes bis cremefarbenes kristallines Pulver |
| Analyse (HPLC) | ≥ 99,01 TP3T |
| Trocknungsverlust | ≤ 0,5% |
| Verbrennungsrückstand | ≤ 0.1% |
| Schwermetalle | ≤ 10 ppm |
| Verpackung | 25 kg net in fiber drum with double polyethylene liner |
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Synonyme: (±)-1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c][2]benzazepine, Mirtazapine, Remeron, Zispin, Norset, Avanza, Mirtazapine API
Mirtazapine is a tetracyclic piperazino-azepine antidepressant that acts as an antagonist at central presynaptic α2-adrenergic autoreceptors and heteroreceptors. By blocking these receptors, it increases noradrenergic and serotonergic neurotransmission—a mechanism distinct from SSRIs and SNRIs. The molecule also shows potent antagonism at 5-HT2 and 5-HT3 receptors, plus significant antihistamine (H1) activity.
First approved in the mid-1990s, mirtazapine is now a standard treatment for major depressive disorder, often chosen when insomnia and appetite loss are prominent. It is available as immediate-release tablets and orally disintegrating tablets. The active pharmaceutical ingredient (API) is manufactured under cGMP and supplied in various particle sizes for solid dosage formulation.
Mirtazapine belongs to the chemical class of piperazino-azepines. Its structure features a fused tetracyclic ring system with a methylpiperazine moiety. The compound is a white to off-white crystalline powder, practically insoluble in water, but freely soluble in methanol and slightly soluble in ethanol. It exhibits no chiral center and is used as the racemate. The molecular formula is C17H19N3, and its molecular weight is 265.35 g/mol.
| Parameter | Technische Daten |
|---|---|
| Analyse (HPLC) | ≥ 99,01 TP3T |
| Trocknungsverlust | ≤ 0,5% |
| Verbrennungsrückstand | ≤ 0.1% |
| Schwermetalle | ≤ 10 ppm |
| Particle Size | D90 ≤ 50 µm (customizable) |
| Residual Solvents | Meets ICH Q3C limits |
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