Pharm-Rx Mirtazapine

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

• USP Mirtazapine RS
• USP Mirtazapine Resolution Mixture RS Mirtazapine.
• Impurity A: 1,2,3,4,10,14b-Hexahydro-2- methylpyrazino[2,1-a]pyrido[2,3-c][2]benzazepine 2- oxide.
• Impurity B: (2-(4-Methyl-2-phenylpiperazin-1-yl)pyridin- 3-yl)methanol.
• Impurity C: (2-Methyl-3,4,10,14b-tetrahydrobenzo[c] pyrazino[1,2-a]pyrido[3,2-f]azepin-1(2H)-one.
• Impurity D: [NOTE—This impurity may be available either as the free base form or as the hydrochloride salt form.] (ERR 1-Apr-2021) 1,2,3,4,10,14b- Hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepine or 1,2,3,4,10,14b-Hexahydropyrazino[2,1-a] pyrido[2,3-c][2]benzazepine hydrochloride. (ERR 1-Apr-2021)
• Impurity E: 4-Methyl-1-(3-methylpyridin-2-yl)-2- phenylpiperazine. Impurity F: 2-Methyl-1,2,3,4-tetrahydrobenzo[c] pyrazino[1,2-a]pyrido[3,2-f]azepin-10(14bH)-one.

Preserve in tight containers, and store at controlled room temperature.