Description: Mirtazapine, is an atypical antidepressant with noradrenergic and specific serotonergic activity. It blocks the α2 adrenergic auto- and heteroreceptors (enhancing norepinephrine 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),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. Â
Dosage: Oral, can swallow with water, do not chew. The initial dose of adult treatment is 15mg (1/2 tablet) once daily, and then gradually increase the dose for optimal efficacy. The effective oral dose is usually 15-45mg (1/2 tablet-1.5 tablet) per day. Patients with liver and kidney damage, mirtazapine clearance decreased, so these patients medication should be noted. The half-life of mirtazapine is 20-40 hours, so medication can be done once a day, before going to bed to take effect better. Can also be sub-service, sooner or later each time. Patients should continue to take medicine, preferably in the symptoms disappear completely 4-6 months after withdrawal. Appropriate doses within 2-4 weeks will have a significant effect. If the effect is not obvious, the dose can be increased until the maximum dose, such as 2-4 weeks after the dose was still no significant effect, should immediately stop the medication .
COA:
Items
Standard
   Result
    Appearance
White or off-white powder
CompliesÂ
Identification
The IR absorption spectrum is accordant with the spectrum obtained with CRS
CompliesÂ
 Solubility
, Practically insoluble in water,freely soluble in anhydrous ethanol
CompliesÂ
specific rotation
-0.10°~+0.10° (anhydrous substance)
+0.001°
Water
≤3.5%
2.8%
Sulfated ash
≤0.10%
0.04%
granularityÂ
80%<75 m
39.28 m
Residual solvents
Ethanol ≤5000ppm
130ppm
Impurity
Impurity A A≤0.10%
ND
Â
Impurity B B≤0.10%
ND
Â
Impurity C C≤0.10%
ND
Â
Impurity D D≤0.10%
ND
Â
Impurity E E≤0.10%
ND
Â
Impurity F F≤0.10%
ND
Â
Individual impurity ≤0.10%
ND
Â
Total impurities ≤0.20%
ND
Microbial limit test
aerobic bacteria≤1000CFU/g
<10CFU/g
Â
fungus≤1000CFU/g
<10CFU/g
Â
Absence of escherichia coli
ND
 Assay
99.0~101.0%(anhydrous substance)
100.0%
Conclusion
Complies to EP7.0
Antidepressant Related materialÂ
Paroxetine Sertraline Fluvoxamine maleate, Citalopram hydrobromide, Duloxetine hydrochloride, Venlafaxine hydrochloride    Duloxetine Bupropion Trazodone Nefazodone Mirtazapine Moclobemide Escitalopram Gabapentin hydrochlorideMirtazapine
Description: Mirtazapine, is an atypical antidepressant with noradrenergic and specific serotonergic activity. It blocks the α2 adrenergic auto- and heteroreceptors (enhancing norepinephrine 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),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. Â
Dosage: Oral, can swallow with water, do not chew. The initial dose of adult treatment is 15mg (1/2 tablet) once daily, and then gradually increase the dose for optimal efficacy. The effective oral dose is usually 15-45mg (1/2 tablet-1.5 tablet) per day. Patients with liver and kidney damage, mirtazapine clearance decreased, so these patients medication should be noted. The half-life of mirtazapine is 20-40 hours, so medication can be done once a day, before going to bed to take effect better. Can also be sub-service, sooner or later each time. Patients should continue to take medicine, preferably in the symptoms disappear completely 4-6 months after withdrawal. Appropriate doses within 2-4 weeks will have a significant effect. If the effect is not obvious, the dose can be increased until the maximum dose, such as 2-4 weeks after the dose was still no significant effect, should immediately stop the medication .
COA:
Items
Standard
   Result
    Appearance
White or off-white powder
CompliesÂ
Identification
The IR absorption spectrum is accordant with the spectrum obtained with CRS
CompliesÂ
 Solubility
, Practically insoluble in water,freely soluble in anhydrous ethanol
CompliesÂ
specific rotation
-0.10°~+0.10° (anhydrous substance)
+0.001°
Water
≤3.5%
2.8%
Sulfated ash
≤0.10%
0.04%
granularityÂ
80%<75 m
39.28 m
Residual solvents
Ethanol ≤5000ppm
130ppm
Impurity
Impurity A A≤0.10%
ND
Â
Impurity B B≤0.10%
ND
Â
Impurity C C≤0.10%
ND
Â
Impurity D D≤0.10%
ND
Â
Impurity E E≤0.10%
ND
Â
Impurity F F≤0.10%
ND
Â
Individual impurity ≤0.10%
ND
Â
Total impurities ≤0.20%
ND
Microbial limit test
aerobic bacteria≤1000CFU/g
<10CFU/g
Â
fungus≤1000CFU/g
<10CFU/g
Â
Absence of escherichia coli
ND
 Assay
99.0~101.0%(anhydrous substance)
100.0%
Conclusion
Complies to EP7.0
Antidepressant Related materialÂ
Paroxetine Sertraline Fluvoxamine maleate, Citalopram hydrobromide, Duloxetine hydrochloride, Venlafaxine hydrochloride    Duloxetine Bupropion Trazodone Nefazodone Mirtazapine Moclobemide Escitalopram Gabapentin hydrochloride