Pharm-Rx Mirtazapine

Product families

Other characteristics

Markets

Healthcare & Pharma

Definition

Mirtazapine contains NLT 98.0% and NMT 102.0% of mirtazapine (C₁₇H₁₉N₃), calculated on the anhydrous basis.

Technology

Pharmaceuticals & Nutraceuticals

FDA Disclaimer

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.

Storage Information

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

USP Reference Standards

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.